Still struggling to turn its manufacturing around, Dr. Reddy's is recalling 569,000 store-brand famotidine tablets in the U.S.

With an FDA committee nod, Novo Nordisk is one step closer to rolling out its key diabetes drug semaglutide—and launch preps are underway.

Ex-Lilly exec Alex Azar may nab the top job at HHS, where he could help pharma navigate some turbulent political waters.

Bristol-Myers aims to get its I-O med Opdivo to cancer patients as early as possible, and a new approval in melanoma would be a step in that direction.

After stirring up a tribal licensing controversy, Allergan has run into a patent setback with big-selling eye medication Restasis.

FDA reviewers flagged data on cardiovascular benefits—and potential eye risks—posed by Novo Nordisk's semaglutide, up for approval later this year.

A recent investigation alleges that Avanir Pharmaceuticals inappropriately marketed its neurological treatment Nuedexta to nursing home residents.

Bracing for generic competition to big-selling Lyrica, Pfizer has won FDA approval for a longer-lasting version that could help it defend sales.

Regulatory