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328 results on '"Drug approval -- Technology application"'

201. StartX Celebrates 10 Years Helping Stanford's Top Tech and Medical Entrepreneurs Solve Real-World Problems

Subjects
Stanford University -- Technology application, Technology application, Entrepreneurs -- Technology application, Drug approval -- Technology application, Business schools -- Technology application, Virtual reality, Medical supplies, Backup software, Biotechnology, Social media, Editors
Abstract

2019 OCT 9 (NewsRx) -- By a News Reporter-Staff News Editor at Biotech Week -- StartX, a nonprofit startup community of more than 1300 Stanford alumni and faculty founders, will [...]

Published
2019

202. FDA Accepts US Merck's Supplemental Biologics License Applications for Keytruda Six-Week Dosing Schedule for Melanoma and Multiple Other Indications

Subjects
United States. Food and Drug Administration -- Technology application, Merck & Company Inc. -- Technology application, Stomach cancer -- Technology application, Pharmaceutical industry -- Technology application, Melanoma -- Technology application, Drug approval -- Technology application, Lymphomas -- Technology application, Hepatocellular carcinoma, Carcinoma, Non-Hodgkin's lymphomas, Tumors, Technology application, Chemistry, Keytruda (Medication)
Abstract

M2 PHARMA-July 12, 2019-FDA Accepts US Merck's Supplemental Biologics License Applications for Keytruda Six-Week Dosing Schedule for Melanoma and Multiple Other Indications (C)2019 M2 COMMUNICATIONS - The US Food and [...]

Published
2019

203. US Food and Drug Administration accepts for review six supplemental Biologics License Applications for Merck's KEYTRUDA

Subjects
United States. Food and Drug Administration -- Technology application, Merck & Company Inc. -- Technology application, Stomach cancer -- Technology application, Pharmaceutical industry -- Technology application, Drug approval -- Technology application, Lymphomas -- Technology application, Carcinoma, Hepatocellular carcinoma, Melanoma, Tumors, Technology application, Chemistry, Keytruda (Medication)
Abstract

M2 PHARMA-July 11, 2019-US Food and Drug Administration accepts for review six supplemental Biologics License Applications for Merck's KEYTRUDA (C)2019 M2 COMMUNICATIONS The US Food and Drug Administration (FDA) has [...]

Published
2019

204. US Food and Drug Administration accepts for review six supplemental Biologics License Applications for Merck's KEYTRUDA

Subjects
United States. Food and Drug Administration -- Technology application, Merck & Company Inc. -- Technology application, Stomach cancer -- Technology application, Pharmaceutical industry -- Technology application, Drug approval -- Technology application, Lymphomas -- Technology application, Carcinoma, Hepatocellular carcinoma, Melanoma, Tumors, Technology application, Business, Keytruda (Medication)
Abstract

M2 EQUITYBITES-July 11, 2019-US Food and Drug Administration accepts for review six supplemental Biologics License Applications for Merck's KEYTRUDA (C)2019 M2 COMMUNICATIONS http://www.m2.com The US Food and Drug Administration (FDA) [...]

Published
2019

205. Isofol Receives Clinical Use Patent Approval in the United States for Drug Candidate arfolitixorin

Subjects
Technology application, Intellectual property, Liver cancer -- Technology application, Cancer -- Technology application, Bevacizumab -- Technology application -- Intellectual property, Drug approval -- Technology application, Breast cancer, Fluorouracil, Tumors, Liver, Editors
Abstract

2019 JUL 9 (NewsRx) -- By a News Reporter-Staff News Editor at Cancer Weekly -- Isofol Medical AB (publ), (Nasdaq First North Premier: ISOFOL), announced approval of a Clinical Use [...]

Published
2019

206. How it's made: recycled fiber in Starbucks cups

Subjects
Starbucks Corp. -- Technology application, Coffeehouses -- Technology application, Drug approval -- Technology application, Sales managers, Vice presidents (Organizations), Recycling, Technology, Paper industry, Technology application, Business, Food and beverage industries
Abstract

FIGURING OUT HOW TO recycle paper into a reusable fiber that is FDA approved to touch food wasn't easy. The patented process by recycled paper company Sustana creates its EnviroLife [...]

Published
2019

207. Digital health

Subjects
United States. Food and Drug Administration -- Information management, Technology application, Innovations, Information management, Laws, regulations and rules, Government regulation, Company systems management, Drug approval -- Technology application, E-health -- Laws, regulations and rules -- Innovations
Abstract

Digital health became an increasingly important focus area for FDA in 2018. After launching the Digital Health Innovation Action Plan in 2017, which is seeking to modify the agency's approach [...]

Published
2019

208. Fertility apps are increasingly being used as contraception, and one has even gained FDA approval

Subjects
United States. Food and Drug Administration -- Technology application, Technology application, Software quality, Contraception -- Technology application, Software -- Technology application, Drug approval -- Technology application, Algorithms, Menstruation, Independent regulatory commissions, Birth control, Medical equipment
Abstract

The Food and Drug Administration recently approved mobile fertility app Natural Cycles as a method of contraception. While Natural Cycles was certified in Europe last year, this is the first [...]

Published
2018

209. END-OF-ARM ROBOTIC TOOL

Subjects
Drug approval -- Technology application, Food -- Technology application, Technology application, Business, Food and beverage industries
Abstract

JLS AUTOMATION * www.jlsautomation.com Designed to handle items such as chocolate-covered snacks, dessert cakes and muffins, the JLS Automation elastomer, end-of-arm robotic tool needs minimal mechanical action to pick and [...]

Published
2018

210. First robotic-assisted total knee replacement performed at MedStar Union Memorial

Subjects
Prostheses and implants -- Technology application, Drug approval -- Technology application, Hip replacement arthroplasty -- Technology application, Technology application, Business, Business, regional
Abstract

Byline: Daily Record Staff MedStar Union Memorial Hospital became the first hospital in Maryland to use robotic arm-assisted technology to perform a total knee replacement when Dr. Henry Boucher replaced [...]

Published
2017

211. Advanced Accelerator Applications Receives FDA Approval for Lutathera(r) for Treatment of Gastroenteropancreatic Neuroendocrine Tumors

Subjects
United States. Food and Drug Administration -- Technology application, Novartis AG -- Technology application, Tumors -- Drug therapy -- Technology application, Drug approval -- Technology application, Pharmaceutical industry -- Technology application, Technology application, General interest, News, opinion and commentary, Lutathera (Medication)
Abstract

Basel: Novartis AG has issued the following press release: Novartis AG (NYSE: NVS) today announced that Advanced Accelerator Applications, a subsidiary of Novartis Groupe S.A., has received US Food and [...]

Published
2018

212. NOVARTIS AG CHF0.50(REGD) Advanced Accelerator Applications Receives FDA Approval for Lutathera(r) for Treatment of Gastroenteropancreatic Neuroendocrine Tumors

Subjects
United States. Food and Drug Administration -- Technology application, Novartis AG -- Technology application, Tumors -- Drug therapy -- Technology application, Drug approval -- Technology application, Pharmaceutical industry -- Technology application, Technology application, General interest, News, opinion and commentary, Lutathera (Medication)
Abstract

London: NOVARTIS AG CHF0.50(REGD) has issued the following news release: Novartis AG (NYSE: NVS) today announced that Advanced Accelerator Applications, a subsidiary of Novartis Groupe S.A., has received US Food [...]

Published
2018

213. Advanced Accelerator Applications Receives FDA Approval for Lutathera(r) for Treatment of Gastroenteropancreatic Neuroendocrine Tumors

Subjects
United States. Food and Drug Administration -- Technology application, Novartis AG -- Technology application, Tumors -- Drug therapy -- Technology application, Drug approval -- Technology application, Pharmaceutical industry -- Technology application, Technology application, General interest, News, opinion and commentary, Lutathera (Medication)
Abstract

Basel: Novartis AG has issued the following press release: Novartis AG (NYSE: NVS) today announced that Advanced Accelerator Applications, a subsidiary of Novartis Groupe S.A., has received US Food and [...]

Published
2018

214. Advanced Accelerator Applications Receives FDA Approval for Lutathera(r) for Treatment of Gastroenteropancreatic Neuroendocrine Tumors

Subjects
United States. Food and Drug Administration -- Technology application, Novartis AG -- Technology application, Tumors -- Drug therapy -- Technology application, Drug approval -- Technology application, Pharmaceutical industry -- Technology application, Technology application, General interest, News, opinion and commentary, Lutathera (Medication)
Abstract

Basel: Novartis AG has issued the following press release: Novartis AG (NYSE: NVS) today announced that Advanced Accelerator Applications, a subsidiary of Novartis Groupe S.A., has received US Food and [...]

Published
2018

215. Advanced Accelerator Applications Receives FDA Approval for Lutathera(r) for Treatment of Gastroenteropancreatic Neuroendocrine Tumors

Subjects
United States. Food and Drug Administration -- Technology application, Novartis AG -- Technology application, Tumors -- Drug therapy -- Technology application, Drug approval -- Technology application, Pharmaceutical industry -- Technology application, Technology application, General interest, News, opinion and commentary, Lutathera (Medication)
Abstract

Basel: Novartis AG has issued the following press release: Novartis AG (NYSE: NVS) today announced that Advanced Accelerator Applications, a subsidiary of Novartis Groupe S.A., has received US Food and [...]

Published
2018

216. Advanced Accelerator Applications Receives FDA Approval for Lutathera(r) for Treatment of Gastroenteropancreatic Neuroendocrine Tumors

Subjects
United States. Food and Drug Administration -- Technology application, Novartis AG -- Technology application, Neuroendocrine tumors -- Drug therapy -- Technology application, Tumors -- Drug therapy -- Technology application, Pharmaceutical industry -- Technology application, Drug approval -- Technology application, Technology application, General interest, News, opinion and commentary
Abstract

Zurich, Switzerland: SIX Swiss Exchange Ltd has issued the following notice: Novartis AG (NYSE: NVS) today announced that Advanced Accelerator Applications, a subsidiary of Novartis Groupe S.A., has received US [...]

Published
2018

217. Advanced Accelerator Applications Receives FDA Approval for Lutathera(r) for Treatment of Gastroenteropancreatic Neuroendocrine Tumors

Subjects
United States. Food and Drug Administration -- Technology application, Novartis AG -- Technology application, Tumors -- Drug therapy -- Technology application, Drug approval -- Technology application, Pharmaceutical industry -- Technology application, Technology application, General interest, News, opinion and commentary, Lutathera (Medication)
Abstract

Basel: Novartis has issued the following press release: Novartis AG (NYSE: NVS) today announced that Advanced Accelerator Applications, a subsidiary of Novartis Groupe S.A., has received US Food and Drug [...]

Published
2018

218. Advanced Accelerator Applications Receives US FDA Approval for LUTATHERA for Treatment of Gastroenteropancreatic Neuroendocrine Tumors

Subjects
United States. Food and Drug Administration -- Technology application, Novartis AG -- Technology application, Tumors -- Drug therapy -- Technology application, Drug approval -- Technology application, Pharmaceutical industry -- Technology application, Technology application, Telecommunications industry, Lutathera (Medication)
Abstract

(GlobeNewswire) - Advanced Accelerator Applications S.A. (NASDAQ:AAAP) (AAA or the Company), a Novartis company and leader in nuclear medicine theragnostics, today announced that it has received US Food and Drug [...]

Published
2018

219. Advanced Accelerator Applications Receives FDA Approval for Lutathera(R) for Treatment of Gastroenteropancreatic Neuroendocrine Tumors

Subjects
United States. Food and Drug Administration -- Technology application, Novartis International AG -- Technology application, Tumors -- Drug therapy -- Technology application, Drug approval -- Technology application, Pharmaceutical industry -- Technology application, Technology application, Business, international, Lutathera (Medication)
Abstract

(GLOBE NEWSWIRE via COMTEX) -- Novartis International AG / Advanced Accelerator Applications Receives FDA Approval for Lutathera(R) for Treatment of Gastroenteropancreatic Neuroendocrine Tumors . Processed and transmitted by Nasdaq Corporate [...]

Published
2018

220. Advanced Accelerator Applications Receives US FDA Approval for LUTATHERA(R) for Treatment of Gastroenteropancreatic Neuroendocrine Tumors

Subjects
United States. Food and Drug Administration -- Technology application, Novartis AG -- Technology application, Medical research -- Technology application, Medicine, Experimental -- Technology application, Tumors -- Drug therapy -- Technology application, Nuclear industry -- Technology application, Drug approval -- Technology application, Pharmaceutical industry -- Technology application, Technology application, Banking, finance and accounting industries, Business, Lutathera (Medication)
Abstract

SAINT-GENIS-POUILLY, France, Jan 26, 2018 (GLOBE NEWSWIRE via COMTEX) -- First-in-class Therapy Demonstrated 79% Improvement in Progression Free Survival in NETTER-1 Phase 3 Study in Midgut NET Patients LUTATHERA marks [...]

Published
2018

221. FDA gives nod to extend the Use of QIAGEN's therascreen

Subjects
United States. Food and Drug Administration -- Technology application, QIAGEN N.V. -- Technology application, Epidermal growth factors -- Technology application, Drug approval -- Technology application, Non-small cell lung cancer -- Drug therapy -- Technology application, Biological products industry -- Technology application, Technology application, Biotechnology industry, Gilotrif (Medication)
Abstract

QIAGEN N.V. is a provider of sample and assay technologies for molecular diagnostics, applied testing, academic and pharmaceutical research. A biotechnology company announced that the U.S. Food and Drug Administration [...]

Published
2018

222. Cagent Vascular Announces CE Mark of Serranator, Next Generation Device for Vessel Dilatation in Peripheral Artery Disease Interventions

Subjects
Drug approval -- Technology application, Angioplasty -- Technology application, Technology application, Business, Business, international
Abstract

Serranator[R] has achieved regulatory approvals from both FDA and European Medicines Agency, paving way for successful commercialization WAYNE, Pa. -- Cagent Vascular, a developer of next generation technology for vessel [...]

Published
2017

223. Advanced Accelerator Applications Announces European Approval of Lutetium (177Lu) Oxodotreotide (Lutathera(R)) for Gastroenteropancreatic Neuroendocrine (GEP-NET) Tumors

Subjects
United States. Food and Drug Administration -- Technology application, Tumors -- Technology application, Drug approval -- Technology application, Technology application, Banking, finance and accounting industries, Business, Lutathera (Medication)
Abstract

SAINT-GENIS-POUILLY, France, Sep 29, 2017 (GLOBE NEWSWIRE via COMTEX) -- Advanced Accelerator Applications S.A. (NASDAQ:AAAP) (AAA or the Company), an international specialist in Molecular Nuclear Medicine (MNM), today announced that [...]

Published
2017

224. FDA agrees to review cancer drug approval applications for Boulder's Array BioPharma

Subjects
United States. Food and Drug Administration -- Technology application, Skin cancer -- Drug therapy -- Technology application, Drug approval -- Technology application, Antineoplastic agents -- Technology application, Biological products industry -- Technology application, Technology application, News, opinion and commentary, Sports and fitness
Abstract

Robyn Hamor, associate scientist, works on an enzyme linked immunosorbent assay at Array BioPharma in Boulder on March 4, 2015. (File Photo) The U.S. Food and Drug Administration has agreed [...]

Published
2017

225. Advanced Accelerator Applications Announces Positive CHMP Opinion Recommending Approval of Lutetium 177Lu Oxodotreotide (Lutathera(R)) for Gastroenteropancreatic Neuroendocrine (GEP-NET) Tumors

Subjects
United States. Food and Drug Administration -- Technology application, Tumors -- Technology application, Drug approval -- Technology application, Technology application, Banking, finance and accounting industries, Business, Lutathera (Medication)
Abstract

SAINT-GENIS-POUILLY, France, Jul 21, 2017 (GLOBE NEWSWIRE via COMTEX) -- Advanced Accelerator Applications S.A. (NASDAQ:AAAP) (AAA or the Company), an international specialist in Molecular Nuclear Medicine (MNM), today announced that [...]

Published
2017

226. Company Profile of TheraPix Biosciences

Subjects
Tourette syndrome -- Drug therapy -- Technology application, Drug approval -- Technology application, Technology application, General interest, News, opinion and commentary
Abstract

Tel Aviv, Israel: Following is the Company Profile of TheraPix Biosciences: Therapix Biosciences Ltd. (NASDAQ: TRPX; TASE: THXBY) is an emerging specialty pharmaceutical company which develops unique cannabinoid technologies for [...]

Published
2017

227. Company Profile of Boreal Genomics

Subjects
Genetic research -- Technology application, Cancer genetics -- Technology application, Biotechnology industries -- Technology application, Drug approval -- Technology application, Technology application, General interest, News, opinion and commentary
Abstract

Vancouver, BC: Following is the Company Profile of Boreal Genomics: At Boreal, we are committed to improving cancer patient care through development of technologies for blood-based detection and monitoring of [...]

Published
2017

228. Company Profile of Boreal Genomics

Subjects
Genetic research -- Technology application, Cancer genetics -- Technology application, Biotechnology industries -- Technology application, Drug approval -- Technology application, Technology application, General interest, News, opinion and commentary
Abstract

Los Altos, CA: Following is the Company Profile of Boreal Genomics : At Boreal, we are committed to improving cancer patient care through development of technologies for blood-based detection and [...]

Published
2017

229. Can-do marketing applications

Author

Chew, Nancy J.

Subjects
Drug approval -- Technology application, Computers -- Usage, Pharmaceutical industry -- Technology application, Biotechnology industry, Business, Pharmaceuticals and cosmetics industries
Published
1993

230. Portable Drum Handlers Designed for Repetitive Applications

Subjects
Materials handling -- Technology application, Drug approval -- Technology application, Technology application, Business, Metals, metalworking and machinery industries
Abstract

Liftomatic Material Handling offers the modular Ergo-Matic line of portable drum handling equipment, which includes a range of models and features for repetitive applications. The line features high lift capability [...]

Published
2018

233. The US FDA & Brigham and Women's Hospital/Harvard Medical School to use Aetion's software platform to re-create RCTs through RWE

Subjects
United States. Food and Drug Administration -- Technology application, Software industry -- Technology application, Drug approval -- Technology application, Medical schools -- Technology application, Technology application, Chemistry, Harvard University. Harvard Medical School -- Technology application
Abstract

M2 PHARMA-May 9, 2018-The US FDA & Brigham and Women's Hospital/Harvard Medical School to use Aetion's software platform to re-create RCTs through RWE (C)2018 M2 COMMUNICATIONS Health care technology company [...]

Published
2018

234. The US FDA & Brigham and Women's Hospital/Harvard Medical School to use Aetion's software platform to re-create RCTs through RWE

Subjects
United States. Food and Drug Administration -- Technology application, Software industry -- Technology application, Drug approval -- Technology application, Medical schools -- Technology application, Technology application, Business, Harvard University. Harvard Medical School -- Technology application
Abstract

M2 EQUITYBITES-May 9, 2018-The US FDA & Brigham and Women's Hospital/Harvard Medical School to use Aetion's software platform to re-create RCTs through RWE (C)2018 M2 COMMUNICATIONS http://www.m2.com Health care technology [...]

Published
2018

235. Wash-down drive technology

Subjects
Aluminum castings -- Technology application, Drug approval -- Technology application, Technology application, Engineering and manufacturing industries
Abstract

NORD DRIVESYSTEMS reports it will be showcasing industry-specific drive solutions at the drinktec exhibition in Germany. The German manufacturer says it draws on an extensive range of standard products with [...]

Published
2017

236. Impact of an electronic antibiotic advice and approval system on antibiotic prescribing in an Australian teaching hospital

Author

Grayson, M Lindsay, Melvani, Sharmila, Kirsa, Sue W, Cheung, Stephen, Korman, Anthony M, Garrett M. Kent, and Thomson, William A.

Subjects
Communicable diseases -- Care and treatment, Drug approval -- Technology application, Online services -- Forecasts and trends, Technology application, Market trend/market analysis, Cable television/data services, Online services, Health
Abstract

The effect of a computer-based infectious diseases electronic antibiotic advice and approval system (IDEA(super 3)S), which could be used as an alternative to the labour-intensive, phone-based approval system, is studied. It was found that IDEA(super 3)S could be used as an additional tool along with routine clinical consultation for appropriately prescribing antibiotics for common indications.

Published
2004

237. Surgery Without the Knife: Mirabilis Medical Announces European Approval for Non-Invasive Uterine Fibroid Treatment

Subjects
Clinical trials -- Technology application, Surgery -- Technology application, Drug approval -- Technology application, Medical offices -- Technology application, Technology application, General interest, News, opinion and commentary
Abstract

Bothell: Mirabilis Medical, Inc has issued the following news release: Mirabilis Medical, a Seattle-area developer of advanced medical technology for non-invasive surgery, announced today CE Mark authorization for marketing of [...]

Published
2017

238. Surgery Without the Knife: Mirabilis Medical Announces European Approval for Non-Invasive Uterine Fibroid Treatment

Subjects
United States. Food and Drug Administration -- Technology application, Clinical trials -- Technology application, Surgery -- Technology application, Drug approval -- Technology application, Technology application, Business, News, opinion and commentary
Abstract

Mirabilis Also Receives FDA Approval to Begin US Clinical Study BOTHELL, Wash., March 23, 2017 /PRNewswire/ -- Mirabilis Medical, a Seattle-area developer of advanced medical technology for non-invasive surgery, announced [...]

Published
2017

239. ViiV Healthcare welcomes European Commission approval of dolutegravir paediatric Type II variation and extension applications

Subjects
Health care industry -- Technology application, Pediatrics -- Technology application, Drug approval -- Technology application, Health care industry, Technology application, General interest, News, opinion and commentary, European Union. European Commission -- Technology application
Abstract

England: ViiV Healthcare group of companies has issued the following news release: ViiV Healthcare has today announced that the European Commission has approved the Type II variation and extension applications [...]

Published
2017

240. Develop Better Oral Medicines With Lipids

Subjects
Drug delivery systems -- Technology application, Lipids -- Technology application, Drug approval -- Technology application, Technology application, General interest, News, opinion and commentary
Abstract

Somerset:Catalent, Inc.has issued the following press release: Date: Thursday, February 2, 2017 Time: 8:30am - 4:00pm Location: San Mateo Marriott San Francisco Airport San Mateo, CA Register today. This one-day, [...]

Published
2017

241. United States : GenMark Diagnostics seeks approval from FDA approval for ePlex sample-to-answer instrument & respiratory pathogen panel

Subjects
Cross infection -- Technology application, Drug approval -- Technology application, Technology application, Business, international
Abstract

A major provider of automated, multiplex molecular diagnostic testing systems, GenMark Diagnostics, Inc., has filed 510(k) applications for its ePlex sample-to-answer instrument and Respiratory Pathogen Panel, with the FDA. In [...]

Published
2016

242. United States : Janssen Submits Two Applications To FDA Seeking Approval Of Simponi Aria (Golimumab) For The Treatment Of Active Psoriatic Arthritis And Active Ankylosing Spondylitis

Subjects
United States. Food and Drug Administration -- Technology application, Ankylosing spondylitis -- Care and treatment -- Technology application, Tumor necrosis factor -- Technology application, Rheumatoid factor -- Technology application, Psoriatic arthritis -- Care and treatment -- Technology application, Drug approval -- Technology application, Antiarthritic agents -- Technology application, Technology application, Business, international, Simponi (Medication)
Abstract

Janssen Biotech, Inc. (Janssen) announced today the submission of two Supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration (FDA) seeking approval of SIMPONI ARIA (golimumab) for [...]

Published
2016

243. Janssen Submits Two Applications To FDA Seeking Approval Of SIMPONI ARIA (golimumab) For The Treatment Of Active Psoriatic Arthritis And Active Ankylosing Spondylitis

Subjects
United States. Food and Drug Administration -- Technology application, Ankylosing spondylitis -- Care and treatment -- Technology application, Tumor necrosis factor -- Technology application, Rheumatoid factor -- Technology application, Psoriatic arthritis -- Care and treatment -- Technology application, Drug approval -- Technology application, Antiarthritic agents -- Technology application, Adults -- Technology application, Technology application, Business, News, opinion and commentary, Simponi (Medication)
Abstract

HORSHAM, Pa., Dec. 20, 2016 /PRNewswire/ -- Janssen Biotech, Inc. (Janssen) announced today the submission of two Supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration (FDA) [...]

Published
2016

244. Advanced Accelerator Applications Announces European Commission Approval of SomaKit TOC(TM)

Subjects
Drug approval -- Technology application, Technology application, Banking, finance and accounting industries, Business
Abstract

SAINT-GENIS-POUILLY, France, Dec 15, 2016 (GLOBE NEWSWIRE via COMTEX) -- Advanced Accelerator Applications S.A. (NASDAQ:AAAP) ('AAA' or 'the Company'), an international specialist in molecular nuclear medicine, today announced that following [...]

Published
2016

245. Biogen's Regulatory Applications for Nusinersen as a Treatment for Spinal Muscular Atrophy Accepted by FDA and EMA

Subjects
United States. Food and Drug Administration -- Technology application, Ionis Pharmaceuticals, Inc. -- Technology application, Spinal muscular atrophy -- Care and treatment -- Technology application, Pharmaceutical industry -- Technology application, Drug approval -- Technology application, Biological products industry -- Technology application, Technology application, General interest, News, opinion and commentary
Abstract

Carlsbad: Ionis Pharmaceuticals, Inc. has issued the following press release: Biogen (NASDAQ: BIIB) today announced that its New Drug Application (NDA) for nusinersen, an investigational treatment for spinal muscular atrophy [...]

Published
2016

246. Biogen's Regulatory Applications for Nusinersen as a Treatment for Spinal Muscular Atrophy Accepted by FDA and EMA

Subjects
United States. Food and Drug Administration -- Technology application, Biogen Inc. -- Technology application, Spinal muscular atrophy -- Care and treatment -- Technology application, Drug approval -- Technology application, Biological products industry -- Technology application, Technology application, General interest, News, opinion and commentary
Abstract

Massachusetts: Biogen, Inc has issued the following news release: Biogen (NASDAQ: BIIB) today announced that its New Drug Application (NDA) for nusinersen, an investigational treatment for spinal muscular atrophy (SMA), [...]

Published
2016

247. Biogen's Regulatory Applications for Nusinersen as a Treatment for Spinal Muscular Atrophy Accepted by FDA and EMA

Subjects
United States. Food and Drug Administration -- Technology application, Spinal muscular atrophy -- Technology application, Drug approval -- Technology application, Biological products industry -- Technology application, Technology application, General interest, News, opinion and commentary
Abstract

Cambridge: Biogen has issued the following news release Biogen (NASDAQ: BIIB) today announced that its New Drug Application (NDA) for nusinersen, an investigational treatment for spinal muscular atrophy (SMA), has [...]

Published
2016

248. United States : Biogens regulatory applications for Nusinersen as a treatment for spinal muscular atrophy accepted by FDA and EMA

Subjects
United States. Food and Drug Administration -- Technology application, Spinal muscular atrophy -- Care and treatment -- Technology application, Drug approval -- Technology application, Technology application, Business, international
Abstract

Biogen today announced that its New Drug Application (NDA) for nusinersen, an investigational treatment for spinal muscular atrophy (SMA), has been accepted by the U.S. Food and Drug Administration (FDA) [...]

Published
2016

249. Biogen's Regulatory Applications for Nusinersen as a Treatment for Spinal Muscular Atrophy Accepted by FDA and EMA

Subjects
United States. Food and Drug Administration -- Technology application, Spinal muscular atrophy -- Care and treatment -- Technology application, Drug approval -- Technology application, Biological products industry -- Technology application, Technology application, General interest, News, opinion and commentary
Abstract

Cambridge: Biogen has issued the following news release (NASDAQ: BIIB) today announced that its New Drug Application (NDA) for nusinersen, an investigational treatment for spinal muscular atrophy (SMA), has been [...]

Published
2016

250. Biogen's Regulatory Applications for Nusinersen as a Treatment for Spinal Muscular Atrophy Accepted by FDA and EMA

Subjects
United States. Food and Drug Administration -- Planning -- Technology application, Spinal muscular atrophy -- Technology application, Drug approval -- Technology application, Biological products industry -- Planning -- Technology application, Company business planning, Technology application, Business, Business, international
Abstract

Nusinersen Granted Priority Review by FDA EMA Plans to Follow Accelerated Assessment Timeline CAMBRIDGE, Mass. -- Biogen (NASDAQ: BIIB) today announced that its New Drug Application (NDA) for nusinersen, an [...]

Published
2016

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