Action Today, the U.S. Food and Drug Administration (FDA) approved Jascayd (nerandomilast) tablets to treat adults with progressive pulmonary fibrosis (PPF). Jascayd was previously approved to treat idiopathic […]

[December 19, 2025] The U.S. Food and Drug Administration (FDA) today qualified total hip bone mineral density (BMD) as assessed by dual energy X-ray absorptiometry (DXA) […]

Bavencio (avelumab) Imfinzi (durvalumab) Tecentriq (atezolizumab) Yervoy (ipilimumab) Cardiac failure FDA decided that no action is necessary at this time based on available information. Invega Sustenna […]

Issued by: Guidance Issuing Office Office of the Commissioner, Office of Clinical Policy and Programs, Office of Clinical Policy, Office of Good Clinical Practice This guidance […]

Issued by: Guidance Issuing Office Office of the Commissioner, Office of Clinical Policy and Programs, Office of Clinical Policy, Office of Good Clinical Practice This guidance […]

FDA conducts inspections to evaluate compliance with risk evaluation and mitigation strategies (REMS) requirements to ensure the drug’s health benefits outweigh the risks for patients. Inspections […]

Docket Number: FDA-2023-D-5021 Issued by: Guidance Issuing Office Office of Inspections and Investigations Office of the Commissioner, Office of Clinical Policy and Programs Center for Biologics […]