The U.S. Food and Drug Administration approved on Tuesday the first drug under its new fast-track program designed to shorten ...

The U.S. Food and Drug Administration said on Tuesday it had approved the first gene therapy for a rare and life-threatening ...

Federal health officials are reviewing the safety of two injectable drugs used to protect babies and toddlers from the RSV ...

U.S. health regulators informed senior executives at Merck, Sanofi and AstraZeneca last week that their approved protective ...

The U.S. Food and Drug Administration announced the approval of the first hematopoietic stem cell transplant therapy to treat ...

The U.S. Food and Drug Administration has approved Itvisma (onasemnogene abeparvovec-brve) for the treatment of spinal ...

For traditional approval, CAR T therapies will need to establish superiority over current standard treatments, including ...

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

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

The U.S. Food and Drug Administration has approved Imfinzi (durvalumab) in combination with standard-of-care FLOT ...

All this data builds Jefferies’ argument: the FDA change could help boost return on investment and therefore drive R&D spend.

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