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Dr. John Gamble Harter, a clinical researcher who pioneered a revised treatment for people suffering from asthma and arthritis, died on July 11 at Shady Grove Adventist Hospital in Rockville, […]

While the Food and Drug Administration is in shutdown, only limited information is available from the agency. However, the Embrace device--a watch-like technology for early detection of seizures that was [...]

By a News Reporter-Staff News Editor at Biotech Week -- iBio, Inc. (NYSE MKT: IBIO) announced the addition of its proprietary iBioLaunch™-produced recombinant C1 esterase inhibitor to the group of [...]

By a News Reporter-Staff News Editor at Biotech Week -- InfraScan, a medical device company specializing in brain injury diagnostic products, announced that it has obtained U.S. Food and Drug [...]

M2 PHARMA-August 7, 2012-Royal Philips Electronics and Celsion Corporation to begin Phase II Study of ThermoDox and MR-Guided HIFU in bone cancer following FDA approval(C)2012 M2 COMMUNICATIONS Healthcare company Royal [...]

M2 EQUITYBITES-August 7, 2012-Royal Philips Electronics and Celsion Corporation to begin Phase II Study of ThermoDox and MR-Guided HIFU in bone cancer following FDA approval(C)2012 M2 COMMUNICATIONS http://www.m2.com Healthcare company [...]

M2 PHARMA-September 20, 2010-FDA extends review period for Avastin approval in advanced HER2-negative breast cancer(C)2010 M2 COMMUNICATIONS 20 September 2010 - US-based biotechnology company Genentech Inc, owned by Swiss-based pharmaceutical [...]

Janssen(R), Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. announced the U.S. Food and Drug Administration (FDA) has approved the Supplemental New Drug Applications (sNDAs) for the use of RISPERDAL(R) CONSTA(R) (risperidone) Long-Acting [...]

AVANT Immunotherapeutics, Inc. (Nasdaq: AVAN) announced that Rotarix(R), an oral, two-dose rotavirus candidate vaccine to prevent rotavirus gastroenteritis in infants, received a favorable recommendation from the U.S. Food and Drug [...]

New and current applications for FDA drug approvals by Canada's Valeant Pharmaceuticals won't be clouded by recent inspections that identified problems at the company's Bausch & Lomb manufacturing plant in [...]

Lifeblood Medical, Inc., has established Cell Preservation Solutions, LLC, which will conduct research and development on Lifeblood Medical's proprietary solution to enhance the technology for applications. 'It is important for [...]

Lifeblood Medical, Inc., has established Cell Preservation Solutions, LLC, which will conduct research and development on Lifeblood Medical's proprietary solution to enhance the technology for applications. 'It is important for [...]

Lifeblood Medical, Inc., has established Cell Preservation Solutions, LLC, which will conduct research and development on Lifeblood Medical's proprietary solution to enhance the technology for applications. 'It is important for [...]

Salvat announce plans to file its Cetraxal Otic solution, with a single-dispensing container (SDC) format, with the U.S. Food and Drug Administration (FDA). The efficacy and safety of the treatment [...]

Salvat announce plans to file its Cetraxal Otic solution, with a single-dispensing container (SDC) format, with the U.S. Food and Drug Administration (FDA). The efficacy and safety of the treatment [...]

Salvat announce plans to file its Cetraxal Otic solution, with a single-dispensing container (SDC) format, with the U.S. Food and Drug Administration (FDA). The efficacy and safety of the treatment [...]

* Lack of proper staffing is the main reason for the huge drug approval backlog at the CFDA, which topped 18,000 applications last year. though China's regulator plans to reduce [...]

Biotechs surpassed big pharmas last year in achieving FDA approvals of new molecular entities (NMEs) and new biologics. The FDA approved about 80 new drug applications (NDAs) and biologic license [...]