The FDA in 2022 announced a ban on the sale of Juul e-cigarettes nationwide, saying the company did not prove that keeping its products on the market “would be appropriate for the protection of ...

The FDA Just Axed 52 Food Standards – Here's What It Means for Your Groceries With fewer standards in place, the information on your food labels might be less reliable than ever.

The FDA has declined to approve a new oncolytic immunotherapy, vusolimogene oderparepvec (RP1), to treat advanced melanoma.

Replimune stock fell after the FDA rejected its RP1 application, citing flaws in the trial design and lack of substantial evidence for approval.

Members of the FDA's Oncologic Drugs Advisory Committee voiced concerns with side effects, proposed dosing and a lack of diversity in GSK's trials.

The agency halts muscular dystrophy drug trials after 3 deaths from liver failure.

The FDA named George Tidmarsh, who has led a number of biotech companies, to be its top drug regulator.

The U.S. Food and Drug Administration said on Monday it has appointed George Tidmarsh, a seasoned biotech executive and longtime Stanford University professor, as the director of the Center for ...

The regulator authorized the company to keep its e-cigarettes on the U.S. market after a federal ban in 2022 had pushed it to the brink of bankruptcy.

The FDA has issued a complete response letter to Replimune indicating it is unable to approve the biologics license application for vusolimogene oderparepvec in combination with nivolumab for the ...

The FDA has issued a huge recall involving ice cream bars that are in 23 states across the country.

Sarepta will continue to ship its gene therapy Elevidys to DMD patients who can still walk independently, arguing the data support the drug's safety.