Drugmakers thought they had the FDA's buy-in to approve a therapy to treat a type of cancer that can quickly turn deadly. The agency, however, rejected it.

Without naming a specific product, Commissioner Marty Makary referred to an investigational therapy, delivered surgically ...

This clinical-stage biopharmaceutical company recently had one of its treatments rejected for FDA approval. Now the company is cutting its workforce.

FDA vouchers are normally a coveted prize for biopharma companies, but a surprise rejection for Disc Medicine’s rare disease drug has biopharma reconsidering.

Moderna announced that the FDA will review its new mRNA flu vaccine, a reversal less than two weeks after the agency refused ...

Corcept Therapeutics Inc. overhyped its Cushing’s syndrome drug’s application to investors before announcing regulators ...

(Bloomberg) -- The US Food and Drug Administration has started making rejection letters that pharmaceutical companies traditionally keep under wraps more easily available to investors and the public, ...

With our free press under threat and federal funding for public media gone, your support matters more than ever. Help keep the LAist newsroom strong, become a monthly member or increase your support ...

Add Yahoo as a preferred source to see more of our stories on Google. Eledon's kidney transplant rejection drug Eledon Pharmaceuticals’ lead asset, tegoprubart, is going to late-stage trials in kidney ...