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With 12 nations signing off on the Trans-Pacific Partnership on Wednesday, the clock has started on ratification of the treaty providing up to eight years of exclusivity for biologics. Read More
The FDA is re-examining its approval, REMS and postmarket policies for opioids in response to a growing abuse epidemic and calls to action from lawmakers. Read More
The FDA’s Psychopharmacologic Drugs Advisory Committee will convene March 29 to review Acadia Pharmaceuticals’ Nuplazid for the treatment of psychosis associated with Parkinson’s disease. Read More
CBER is asking biologics manufacturers to allow the center’s regulatory review, compliance and other relevant staff to visit facilities to help them better understand the biologics industry. Read More
Several major drugmakers are exploring development of a vaccine to prevent the Zika virus as the mosquito-borne disease spreads quickly throughout the Western Hemisphere. Read More
One week after accusing Gilead Sciences of promoting an HIV drug off-label, an AIDS nonprofit is suing the company for allegedly “manipulating the patent system” to ward off generic competition for another medication. Read More
Eleven healthcare groups — including the Generic Pharmaceutical Association — are asking a Senate committee to examine alleged industry abuse of REMS safeguards as a possible cause of rising drug prices. Read More
Drugmakers interested in establishing bioequivalence for their products have a treasure trove of data to dig through, as the FDA has just added 35 new product-specific guidances and updated 12 more. Read More