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The head of CDER’s Office of Compliance is removing herself from all substantive policy decisions after her husband became part-owner in a law firm with pharmaceutical clients. Read More
FDA Approves Label Changes for Merck’s Noxafil Antifungal
PharMEDium Recalls 32 Lots of Norepinephrine Bitartrate Over Discoloration
Dr. Reddy’s Lands Tentative Approval for Generic Toviaz
Pluristem’s PLX-PAD Cells Win Orphan Drug Designation
BIO Changes Name to Biotechnology Innovation Organization
EU Delays Clinical Trials Portal Launch
Baxalta, Symphogen Partner to Develop Immuno-Oncology Therapies Read More
Roche has settled its legal feud over Tarceva with Glenmark Pharmaceuticals, with both sides agreeing to drop lawsuits over patent rights in India. Read More
Last year was a productive one for the FDA’s CDER, which approved 45 novel drugs — an increase from its 2006 to 2014 average of 28, according to the agency’s 2015 Novel New Drugs Summary released Monday. Read More
Roughly a fifth of cancer clinical trials fail to recruit enough participants, creating a “major barrier to progress” for developing new therapies, according to a paper published in the Journal of the National Cancer Institute. Read More
A Los Angeles area supplement provider has been hit with an FDA warning letter for selling unapproved drugs for conditions ranging from kidney stones to stroke prevention. Read More
Dr. Reddy’s Laboratories has adopted a unique strategy to bypass legal issues surrounding its generic version of Nexium: changing the color of its capsules. Read More