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As the FDA’s decision date on GSK’s new drug application (NDA) for daprodustat — its chronic kidney disease anemia drug candidate — approaches, an FDA advisory panel said Wednesday that it favors the drug for kidney patients on dialysis but not for patients who aren’t. Read More
The FDA is falling under the political spell that “more drugs, and faster” is the best way to serve the healthcare needs of American citizens, according to a new report that also criticizes the agency’s lack of transparency and reliance on industry funding. Read More
In a new draft guidance released Thursday, the FDA laid out its thinking on developing drugs that treat Clostridioides difficile infection (CDI), as well as those that prevent and reduce recurrence of the condition. Read More
The FDA scolded Jubilant Pharma for failing to properly investigate batch discrepancies and keep written records, among other deficiencies, during an inspection of its Indian facility in Sikanderpur Bhainswal, Uttaranchal conducted from July 20 to Aug. 1. Read More
Acadia Pharmaceuticals has filed three separate patent infringement suits in an attempt to block generic formulations of its only approved drug, Nuplazid (pimavanserin). Read More
As part of its commitments under the recently reauthorized Generic Drug User Fee Amendments (GDUFA), the FDA has set out a list of eight science and research priorities for generics for fiscal year 2023 with a focus on impurities and bioequivalence. Read More
The FDA is pushing off or rescheduling several advisory committee meetings this week — including one to consider what could become of the first over-the-counter (OTC) daily oral contraceptive in the U.S., Opill. Read More