The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) has unveiled new improvements to its medical device recalls database, allowing members of industry and the ...

The FDA has told Eli Lilly to study possible heart, liver and other risks tied to its new obesity drug Foundayo.

The US Food and Drug Administration (FDA), in updating the Purple Book, its database of FDA-licensed biologic products, will also include exclusivity information for biological products as well as a ...

Stoboclo and Osenvelt were approved as interchangeable biosimilars for bone loss conditions, potentially reducing costs and increasing access. Darzalex Faspro was approved for high-risk smoldering ...

The US Food and Drug Administration announced on Thursday its approval of a new, higher-dose Wegovy (semaglutide) injection. The 7.2 mg dosage, called Wegovy HD, is intended for weight loss and ...

Key Takeaways. Draft guidance targets reduction/elimination of nonhuman primate testing for monoclonal antibodies, signaling higher regulatory receptivity to alternative nonclinic ...

Health system pharmacists and clinicians are monitoring a wave of drug approvals expected throughout 2026, including first-in-class therapies and expanded uses of existing drugs with implications for ...

The Food and Drug Administration (FDA) has approved some medications for weight loss. If a medication is FDA-approved, it means the FDA has determined it’s safe and effective for a certain use.