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London: Element Materials Technology has issued the following press release: Element Materials Technology (Element), a global leader in materials and product qualification testing, inspection, and certification services (TIC), today shared [...]

Of Counsel Benjamin Zegarelli and Associate Pat Ouellete discussed the health care regulations governing medical devices and software and shared how to stay informed and navigate the evolving landscape of [...]

NEWTON, Mass. -- Lumicell, Inc., a privately held company focused on innovative fluorescence-guided imaging technologies for cancer, today announced the Medical Imaging Drugs Advisory Committee (MIDAC) of the U.S Food [...]

Helsinki, Finland: Applications for five communication projects totaling 81.04 million euros in funding from the Networking Europe initiative are being made by Finnish operators to the European Commission. On February [...]

Beyond traditional regulatory concerns, the U.S. Food and Drug Administration (FDA) is currently navigating the challenges of usability, equity, performance bias, continuous learning, and accountability in response to an ever [...]

(GlobeNewswire) - ProLynx Inc., a biotech company with a unique technology for tunable half-life extension of drugs, announced publication of a paper entitled Could a Long-Acting Prodrug of SN-38 be [...]

Shanghai Bangyao Biotechnology was honored with the 'Star Enterprise' title in the 'Second Ignite Heat List' by CIC Ignition Consulting. The company, known for its gene editing technology, has multiple [...]

CSPC Pharmaceutical Group. Recently, the Shandong Provincial Department of Science and Technology issued the 'Notice on the Release of Shandong Province Key Research and Development Plan (Major Scientific and Technological [...]

Robots Destroy Germs in Healthcare Facilities SAN ANTONIO -- Xenex Disinfection Services, the world leader in UV disinfection technology for healthcare facilities, today announced it has filed a De Novo [...]

The European Commission recently approved the plan of the Interreg program supporting cross-border developments, so applications can start from the beginning of next year, Minister of Foreign Affairs and Trade [...]

Results From RESET-RA Study Will Support FDA Submission for Approval of This Promising Treatment Approach for RA VALENCIA, Calif. -- SetPoint Medical, a clinical-stage healthcare company dedicated to patients with [...]

T-Cell Select reagent kit simplifies the T-SPOT.TB test laboratory workflow through automation expanding access to the most sensitive latent TB test on the market WALTHAM, Mass. -- PerkinElmer's (NYSE: PKI) [...]

SetPoint Medical, a clinical-stage healthcare company dedicated to patients with chronic autoimmune diseases, reported the enrollment of the first participant in Stage 2 of the company's RESET-RA pivotal study. The [...]

Scope of Work: Construction of 200-MW electrolysis plant in Normandy. Description: The distribution of the state funds will hinge on the approval from the European Commission. The 200-MW electrolyser will [...]

DiRx adopts Glassbox's solutions to enable frictionless pharmacy-to-patient digital journeys NEW YORK -- Glassbox, the leading provider of digital experience analytics for web and mobile applications, today announced that DiRx, [...]

Harbour BioMed ('HBM', HKEX: 02142) announced that the China National Medical Products Administration (NMPA) has approved its Investigational New Drug (IND) applications for HBM4003, a next-generation, fully human anti-CTLA-4 monoclonal [...]

The Ministry of Economy and Innovation intends to receive 40 million from the Ministry of Environment, which administers the Modernization Fund established by the European Union, by the end of [...]

Indias drug regulatory authority is likely to take up Zydus Cadila's application seeking Emergency Use Authorisation (EUA) for its Covid-19 vaccine this week. If it gets approval, it will be [...]

Hyderabad-based Bharat Biotech today said that the USFDA had earlier communicated that no new Emergency Use Authorisation (EUA) will be approved for covid vaccines, a day after its US partner [...]

RheaVita, a company pioneering continuous freeze-drying technology for biopharmaceutical products, announced today that the company has closed a EUR 2.5 million Series A Financing. The round was co-led by Novalis [...]

Applications Based on Progression-Free Survival, Overall Survival, and Objective Response Rate Data From Respective Pivotal Phase 3 Trials Merck, known as MSD outside the United States and Canada, and Eisai [...]

AbbVie (NYSE: ABBV) today announced that it has submitted applications to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) seeking approval for RINVOQ (upadacitinib) for the [...]

Micron Biomedical, Inc. (Micron) recently received a second tranche of funding ($2.6M) to continue clinical development of its microneedle-based technology for measles and rubella vaccination from the Bill & Melinda [...]

AMERI Holdings, Inc. (NASDAQ: AMRH) ('Ameri'), announced that its proposed amalgamation partner Jay Pharma Inc. ('Jay Pharma' or 'the Company') has announced the addition of new senior staff as the [...]

Roche has received approval from the US Food and Drug Administration (FDA) for Phesgo, in combination with intravenous (IV) chemotherapy, to treat early and metastatic human epidermal growth factor receptor [...]

Royal Philips (NYSE:PHG) announced today that FDA has granted premarket approval for the companys HeartStart FR3 and HeartStart FRx automated external defibrillators. The HeartStart FR3 is a professional-grade AED. It [...]

(GlobeNewswire) - June 23, 2020 Amsterdam, the Netherlands and Cambridge, MA Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced that the Center for Devices [...]

(GLOBE NEWSWIRE via COMTEX) -- June 23, 2020 Amsterdam, the Netherlands and Cambridge, MA - Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced that [...]

Aladdin Healthcare Technologies SE ('Aladdin', ISIN: DE000A12ULL2), a leading developer of Artificial Intelligence (AI) based healthcare diagnostics and drug discovery applications, gained approval by the Dementias Platform UK (DPUK) for [...]

On 13th May, the European Commission's eHealth Network published its interoperability guidelines for approved contact tracing mobile applications in the EU, guiding developers when designing and implementing applications and backend [...]

The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of two supplemental Biologics License Applications (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of SIMPONI [...]

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of two supplemental Biologics License Applications (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of [...]

Small-volume presentation now available exclusively in FDA-approved ready-to-administer prefilled syringe LAKE ZURICH, Ill. -- Fresenius Kabi announced today the availability in the United States of preservative-free Heparin Sodium Injection, USP [...]

Approvals Based on Findings from the Phase 3 DRIVE-SHIFT Trial Evaluating a Switch to DELSTRIGO KENILWORTH, N.J. -- Merck (NYSE: MRK), known as MSD outside the United States and Canada, [...]

Merck, known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has accepted for review six supplemental Biologics License Applications (sBLAs) to [...]

Common concentration now available exclusively in FDA-approved ready-to-administer prefilled syringe LAKE ZURICH, Ill. -- Fresenius Kabi announced today the immediate availability in the United States of Neostigmine Methylsulfate Injection, USP [...]

Toronto CoolSculpting, a Toronto-based clinic offering innovative non-invasive aesthetic procedures, is pleased to offer FDA approved CoolSculpting to Torontonians looking to achieve the body contour they desire. The procedure is [...]

First and only FDA-approved lipid emulsion to address nutritional needs of pediatric patients suffering from life-threatening condition LAKE ZURICH, Ill. -- Fresenius Kabi, a global health care company that specializes [...]

Our CBD. Your Health.On June 25, 2018, the U.S. Food and Drug Administration (FDA) approved Epidiolex, a pharmaceutical-grade cannabidiol (CBD) oil. This non-intoxicating organic compound, extracted from cannabis, is the [...]

M2 PRESSWIRE-August 21, 2018-: EyeGate Announces Enrollment of First Patient in PRK Pilot Study (C)1994-2018 M2 COMMUNICATIONS RDATE:20082018 WALTHAM, MA. -- EyeGate Pharmaceuticals, Inc. (NASDAQ: EYEG) a clinical-stage, specialty pharmaceutical [...]

NEW YORK -- CooperKatz & Company today announced its partnership with three new clients: INSIGHTEC, Pager and WAHVE Accounting. While each is distinct in its offerings, all three organizations share [...]

M2 PRESSWIRE-April 12, 2018-: FDA streamlining cancer diagnostics development (C)1994-2018 M2 COMMUNICATIONS RDATE:12042018 FDA will release three new guidance documents Thursday that are intended to encourage development of next-generation sequencing [...]

(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 [...]

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 [...]

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 [...]

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 [...]

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) [...]

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 [...]

RUBY-FILL is a cutting-edge technology for PET MPI for diagnosis of coronary artery disease Jubilant Life Sciences' wholly own subsidiary Jubilant Pharma, through one of its units Jubilant DraxImage Inc. [...]