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French authorities are calling for the withdrawal of Anuh Pharma’s GMP certificate after an inspection turned up 24 alleged GMP deficiencies. Read More
A House committee is pressing the FDA on how it’s dealing with drug adulteration for economic reasons, citing the infamous 2008 heparin contamination scandal that killed at least 81 and infected hundreds more as a prime example. Read More
A non-profit group is pressing the National Institutes of Health to bypass the patent rights of a drugmaker in a bid to lower the drug’s price, marking at least the third time the group has attempted this. Read More
The FDA has made final decisions on roughly two-thirds of the GDUFA backlog of long-standing applications since the program’s fiscal 2013 inception, and met its final hiring goals 11 months ahead of schedule, the agency says in its fiscal 2015 GDUFA report to Congress. Read More
The biosimilars market could exceed $390 billion in value over the next five years, but only if nations improve the competitive landscape, according to a new market analysis. Read More
Despite limited data and only one positive Phase 3 trial, an FDA panel voted 12‒2 to recommend Acadia Pharmaceuticals’ Nuplazid for treating psychosis associated with Parkinson’s disease. Read More