In November 2025, the U.S. Food and Drug Administration (FDA) issued several approvals across oncology and supportive care.

The FDA plans to begin requiring one clinical study, instead of the standard two, for medical products before consideration ...

The U.S. Food and Drug Administration (FDA) today published more than 200 complete response letters (CRLs) issued between 2002 and 2024. FDA reports that it has only published CRLs sent to companies ...

In a milestone moment for chronic pain management, Tonix Pharmaceuticals announced on August 15, 2025, that its novel ...

The FDA is expected to decide on treatments for breast cancer, EBV+ post-transplant lymphoproliferative disease, focal segmental glomerulosclerosis, presbyopia, and severe allergic reactions.

The U.S. Food and Drug Administration approved an Investigational New Drug (IND) application using efficacy data solely from ...

Larimar Therapeutics, Inc. has announced a refined timeline for submitting a Biologics License Application (BLA) for its treatment nomlabofusp, aimed at addressing Friedreich's Ataxia (FA). Based on ...

Dec 3 (Reuters) - The U.S. Food and Drug Administration has approved Axogen's nerve repair graft, the health regulator said ...

In 2024, the FDA granted a record 63 designations to antibody drug conjugates (ADCs), nearly double the previous high of 35 ...

FDA approval describes when the Food and Drug Administration (FDA) deems a medical product safe and effective for its intended use based on scientific data and testing. Before people use a medical ...

Interactions with FDA over the past year have provided clear expectations for the path to submission of the nomlabofusp BLA Written FDA recommendations for safety database include a total of at least ...