The Latest Breaking News from Food and Drug Administration

The Food and Drug Administration says it will begin cracking down on e-cigarettes that have used synthetic nicotine to skirt oversight

The Food and Drug Administration and the Centers for Disease Control and Prevention recently authorized a second booster shot of the Pfizer/BioNTech and Moderna COVID-19 vaccines for those age 50 and older. The recommendation follows a study out of Israel recently published in The New England Journal of Medicine.

Cigarettes that recently gained authorization from the Food and Drug Administration to be marketed as products that can help smokers cut back are hitting Chicago-area stores this week — the first place in the country where they will be sold.

Biofrontera Inc (NASDAQ: BFRI) shares are trading significantly higher Wednesday after the company announced it received U.S. Food and Drug Administration approval for its cGMP laboratory in Germany.

BriaCell Therapeutics Corp (NASDAQ: BCTX) shares are trading higher Wednesday after the company announced the U.S. Food and Drug Administration granted Fast Track status to Bria-IMT for the treatment of metastatic breast cancer.

Biopharma stocks are sensitive to a key binary event called the PDUFA date, the date by which the Food and Drug Administration is required to give its verdict on a regulatory application filed with it.

A panel of the Food and Drug Administration’s expert advisers on Wednesday voted 6 to 4 against approving Amylyx Pharmaceuticals’ treatment for ALS. The FDA now has until June 29 to decide whether to follow the panel’s advice or let the closely watched drug on to the market.

The Food and Drug Administration’s decision opens a fourth dose of the Pfizer or Moderna vaccines to those people at least four months after their previous booster.

Here's a roundup of top developments in the biotech space over the last 24 hours:

The Food and Drug Administration meets next week to review a closely watched drug for ALS, or Lou Gehrig’s disease, following months of lobbying by patient groups and congressional lawmakers

The psychedelics space was shaken up on the news that MindCure Health (OTC:MCURF) was shutting down operations. After a review process, the company’s board decided that MindCure’s business plan required more capital that it could gather under current market conditions, thus shutting down operations was considered the best move to preserve…