A senior US Food and Drug Administration official who recently oversaw the agency's banning of a coloring linked to cancer ...

In the lawsuit, Krystena Murray alleges she “was turned into an unwitting surrogate, against her will” and had to surrender ...

An official who oversees a team at the Food and Drug Administration that reviews Neuralink Corp. devices was fired, according ...

Innate Pharma SA (IPHA) announced that the FDA has granted Breakthrough Therapy Designation to lacutamab for treating adults ...

The Trump administration is tearing down both regulations and the federal government that enforces them. The consequences will be enormous.

Even so: The Trump administration has indicated it has an appetite for investing in AI. In January, President Donald Trump ...

The U.S. Food and Drug Administration has approved a new drug application for a tablet version of Evrysdi (risdiplam) for ...

Teva Pharmaceutical Industries and partner Alvotech said the Food and Drug Administration agreed to review their AVTO6 ...

Alvotech and Teva Pharmaceuticals said on Tuesday that the U.S. FDA has accepted for review a Biologics License Application ...

TURMOIL AT HHS — The past weekend brought a chaotic purge of the federal workforce across the nation’s health agencies, POLITICO’s Adam Cancryn, Megan Messerly and David Lim report.

Chimerix (CMRX) announced the FDA has accepted its New Drug Application, or NDA, seeking accelerated approval for dordaviprone as a treatment ...

Alvotech (ALVO) and Teva Pharmaceuticals (TEVA) announced that the FDA has accepted for review a Biologics License Application, or BLA, for ...