March 11 (Reuters) - The U.S. Food and Drug Administration said on Wednesday it has introduced a unified platform designed to ...

A key US Republican senator said he’s launched an investigation into the Food and Drug Administration’s recent denials of treatments for rare diseases, adding political pressure on an agency that’s ...

By Ahmed Aboulenein and Julie Steenhuysen WASHINGTON, March 10 (Reuters) - The U.S. FDA approved leucovorin, a decades-old generic drug, to treat a rare genetic disorder which causes autism-like ...

The prescription drug leucovorin is getting a label update, though it’s not what that the US Food and Drug Administration suggested might be coming during a White House briefing in September, when ...

Amid the company’s efforts to resolve issues raised during an FDA inspection early last year, Novo Nordisk’s operating base in Plainsboro, New Jersey—already the recipient of a recent Form 483—has ...

March 4 () - PepGen said on Wednesday that the U. Food and Drug Administration has placed ‌a partial clinical hold on its mid‑stage trial of ‌a rare muscle disease drug, sending its shares plunging ...

Makary pointed to three bottlenecks: hospital contracting; ethical reviews and approvals; and the Investigational New Drug ...

WASHINGTON, Feb 1 (Reuters) - The U.S. Food and Drug Administration on Sunday began accepting requests to participate in its PreCheck pilot program, designed to boost domestic drug supply by speeding ...

March 3 (Reuters) - The U.S. Food and Drug Administration has issued warning letters to 30 telehealth companies for making ...

Add Yahoo as a preferred source to see more of our stories on Google. FILE PHOTO: FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S ...

Dr. Céline Gounder, an internist, epidemiologist and infectious disease specialist, is a CBS News medical contributor as well as senior fellow and editor-at-large for public health at KFF Health News.