The culture of academic medicine needs to change, FDA Commissioner Marty Makary, MD, MPH, said at an event sponsored by The Hill.

MENOPAUSAL THERAPY IN FOCUS — The FDA will hold a panel discussion Thursday on hormone therapy for menopausal women, a pet issue for Commissioner Marty Makary that’s separately garnered attention in the states and on social media.

The U.S. FDA's panel of independent advisers on Thursday recommended against GSK's blood cancer drug Blenrep, citing concerns about previously documented risks of eye-related side effects, sending the British drugmaker's U.

The comeback story of belantamab mafodotin (Blenrep) hit a roadblock Thursday as the FDA's Oncologic Drugs Advisory Committee (ODAC) voted that the drug does not have a favorable benefit-risk profile in combination with either of two different regimens for patients with relapsed and refractory multiple myeloma.

Prestige Consumer Healthcare Inc. issued a voluntary recall for more than 10,000 cases of honey cough syrup on June 17.

SH-110, a liquid cancer treatment for glioma, earned orphan drug status from the FDA, helping patients who struggle to swallow pills access therapy.

U.S. inspectors have uncovered new and dangerous breakdowns in drugmaking at an Indian factory owned by Sun Pharma that produces generic medications for American consumers.