Delivery Method: Via Email Product: Drugs Issuing Office: Center for Drug Evaluation and Research (CDER) United States WARNING LETTER December 12, 2025 RE: 719257 Dynamic Health […]

Action The U.S. Food and Drug Administration (FDA) approved Accrufer (ferric maltol) capsules to treat pediatric patients ages 10 and older with iron deficiency. Accrufer was initially […]

Action The U.S. Food and Drug Administration (FDA) approved Myqorzo (aficamten) tablets to treat adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and […]

Summary Company Announcement Date: December 22, 2025 FDA Publish Date: December 22, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Elevated levels of lead […]

Docket Number: FDA-2023-D-2204 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA or Agency) is announcing the availability […]

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 […]