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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
The FDA is working to develop and finalize a handful of new guidances on bringing complex generics to market — including complicated medicines that may require alternate methods of establishing bioequivalence, as well as drug-device combination products that may be blocked by iterative patents. Read More
The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended approval for a single generic medicine and expansions of indications for six other drugs, during a light meeting this past month. Read More