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.

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 Food and Drug Administration is asking Eli Lilly to gather more safety data on its new weight loss pill, Foundayo, ...

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 ...

Add Yahoo as a preferred source to see more of our stories on Google. The US Food and Drug Administration (FDA) has approved Rocket Pharmaceuticals’ Kresladi (marnetegragene autotemcel) in leukocyte ...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you ...

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 Draft guidance targets reduction/elimination of nonhuman primate testing for monoclonal antibodies, signaling higher regulatory receptivity to alternative nonclinic ...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