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The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended seven new products for European Commission approval, including one biosimilar and two orphan medicines, one being an advanced cell therapy. Read More
The FDA outlined how it will use information requests and the newly established discipline review letter — which originates from specialized staff concerning their portion of an ANDA review, such as bioequivalence, quality or labeling. Read More
The FDA continued to issue a larger number of complete response letters to generics manufacturers last month — dropping from a spike in October, but still higher than any single month in the previous fiscal year. Read More
The FDA should not approve generics of Glaxo Smith Kline’s asthma drug Advair Diskus that depend on multiple-batch studies to show pharmacokinetic bioequivalence, according to Mylan. Read More
The FDA fleshed out its public numbers on ANDA approvals for the first month of GDUFA II, notably underscoring 26 first-cycle approvals, plus two tentative. Read More
The FDA approved Invidior’s Sublocade, the first once-monthly buprenorphine injectable as a medication-assisted treatment for opioid use disorder. Read More