Dec 9 (Reuters) - The U.S. Food and Drug Administration said on Tuesday it had approved the first gene therapy for a rare and ...

Dec 9 (Reuters) - The U.S. Food and Drug Administration approved on Tuesday the first drug under its new fast-track program ...

Food and Drug Administration officials have opened a safety review of two injectable drugs used to protect babies and ...

Zevaskyn, the first gene therapy for recessive dystrophic epidermolysis bullosa, showed significant wound healing in phase 3 ...

U.S. health regulators informed senior executives at Merck, Sanofi and AstraZeneca last week that their approved protective RSV treatments for infants would face fresh safety scrutiny following ...

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

The approval of Emeprev will help veterinary professionals by providing an in-clinic antiemetic option.

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

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

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

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

Except for public health advocates (72% opposed), more than 60% of each speaker type supported approval. Patients and family members with drug experience had the highest support for approval (99%), 12 ...