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Drug Approval Process

Sarepta Defies FDA Request to Halt Elevidys Shipments

The FDA’s call for a full suspension follows three liver injury deaths in its gene therapy trials.

Sarepta Shares Plummet on FDA Review of Elevidys Following Third Patient Death

FDA Advisers Recommend Against Approval of GSK’s Myeloma Drug Blenrep

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Sarepta Halts Elevidys Shipments for Non-Ambulatory Patients After Second Fatal Liver Failure

FDA Declares Semaglutide Shortage Over, Impacting Compounded Drug Market

FDA Proposes Removal of Ineffective Oral Phenylephrine from Cold Medicines

Pfizer Withdraws Sickle Cell Drug Oxbryta Over Safety Concerns

New Study Links Ozempic to Increased Risk of Suicidal Thoughts

Eli Lilly's Zepbound Shows Promise in Reducing Heart Failure Risks

FDA Issues Warning on Overdoses from Compounded Semaglutide Injections