Amid recent backlash stemming from market withdrawals and trial delays, the FDA seeks to further clarify its requirements for ...

You don't need a prescription to purchase a test that will tell you whether you're sick with COVID or the flu.

Tirzepatide is the active ingredient in Zepbound, the FDA approved prescription medicine for Obstructive Sleep Apnea.

Recognizing the increased use of artificial intelligence in the development of new therapies, the U.S. FDA on Monday released ...

Among the FDA’s pending decisions for this quarter are Vertex’s non-opioid pain drug and Sanofi’s RNA interference therapy ...

By the end of March, the regulator could clear a highly anticipated pain drug from Vertex and a heart drug that’s critical to Alnylam’s future.

Breakthrough Therapy Designation granted based on key positive data from the Phase 2b (RIZE) study and current unmet medical need in congenital ...

a medical doctor and director of the FDA's Office of Cosmetics and Colors, said Thursday in a news release announcing the agency's action. The agency's proposed rule falls short of a ban on talc ...

The document follows the agency’s first digital health advisory meeting and a final guidance on postmarket updates to AI ...

The Food and Drug Administration is proposing a rule that cosmetic companies would have to take extra steps to ensure that ...

Priority review granted for CUTX-101 with PDUFA target action date set for June 30, 2025Cyprium is eligible to receive royalties and up to $129 ...

Gemtesa is approved for men with overactive bladder symptoms who are receiving pharmacologic treatment for benign prostatic hyperplasia.