Empower Pharmacy, a Houston-based compounding pharmacy, has been sanctioned by the FDA and other states in the past decade.

In discussions with multiple potential animal health company partners to collaborate to bring Canalevia®, conditionally approved for CID, to regulatory approval and commercialization for general ...

According to today's announcement from the FDA, an estimated 40% of the food industry has committed to voluntarily phasing ...

The U.S. Food and Drug Administration has extended its review of Bayer's experimental menopause relief drug, the German company said on Friday.

EMA recommends Gilead Sciences' Lenacapavir for HIV prevention, with FDA approval and generic options available soon.

BAYRY wins FDA nod to expand Kerendia's label, making it the only approved non-steroidal MR antagonist for two major ...

Among reasons for the rejection, the agency cited a lack of US patient representation in the STARGLO trial assessing ...

Oncologic Drugs Advisory Committee (ODAC) has voted against the benefit/risk profile of GSK’s Blenrep (belantamab mafodotin) ...

GSK (GSK) stock slips as FDA advisors vote against the approval of a combination regimen involving thecompany's blood cancer drug Blenrep. Read more here.

Although Sarepta initially appeared to have avoided the worst possible outcome for Elevidys—a market withdrawal—thanks to the gene therapy’s new black box warning, the FDA is signaling stronger ...

Sarepta would need to conduct new analyses to validate the safety of Elevidys—which has had U.S. shipments paused by the company over a mounting string of controversies—to the FDA, Endpoints News and ...