The Latest Breaking News from FDA

Florida supreme court upholds congressional map that weakens Black voters’ influence

Ruling is a win for Republicans, who anticipate losing US House seats in next year’s midterm elections

The Guardian - US · Jul 17, 2025

3-Parent Babies Born Healthy in the U.K.

The FDA blocked a similar successful treatment for mitochondrial disease a quarter of century ago.

Reason · Jul 17, 2025

US Authorizes Juul To Market Vaping Products

Juul Labs said Thursday that the US Food and Drug Administration had officially authorized the e-cigarette maker to market its vaping system and refill capsules in the United States.

International Business Times · Jul 17, 2025

FDA Lifts Pause On Kezar's Liver Drug Trial—Next Stop Lupus Study

The Division of Hepatology and Nutrition of the U.S. Food and Drug Administration lifted the partial clinical hold on Kezar Life Sciences Inc.‘s (NASDAQ:KZR) completed PORTOLA Phase 2a trial evaluating zetomipzomib in autoimmune hepatitis (AIH).

Benzinga · Jul 16, 2025

Big Bucks For Better Barks: Gallant Lands $18M To Bring Game-Changing Stem Cell Therapies To Pets

San Diego biotech startup Gallant just raised $18 million in a Series B financing round, furthering its quest to deliver the first ready-to-use stem cell therapy through conditional U.S. Food and Drug Administration approval. But the company isn't directing those funds toward the treatment of sick humans. Rather, it's wants…

Benzinga · Jul 16, 2025

Tempus AI Stock Is Rising Wednesday: What's Happening?

Tempus AI Inc (NASDAQ:TEM) shares are trading higher Wednesday after the company announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its ejection fraction software.

Benzinga · Jul 16, 2025

Trump administration is pushing for psychedelic therapy. Will it help or hamper the field?

US health secretary Robert F Kennedy Jr said he wants psychedelic therapies approved within a year, surprising even the staunchest supporters of the drugs.

Euronews · Jul 16, 2025

Will RFK Jr.'s push for psychedelic therapy help or hamper the emerging field?

Health Secretary Robert F

The Independent UK · Jul 16, 2025

Fourth Circuit Rejects Claim that West Virginia Abortion Law Is Preempted

A mifepristone manufacturer is unsuccessful in evading West Virginia's prohibition on abortion, even when performed by medication.

Reason · Jul 15, 2025

GSK Seeks FDA Nod To Broaden RSV Vaccine For Younger At-Risk Adults

On Monday, the U.S. Food and Drug Administration (FDA) agreed to review GSK plc’s (NYSE:GSK) application to extend the indication of Arexvy (Respiratory Syncytial Virus Vaccine, Adjuvanted) to adults aged 18-49 who are at increased risk.

Benzinga · Jul 15, 2025