FDA approved label changes for Breyanzi and Abecma, easing access by reducing monitoring rules and eliminating REMS safety program requirements.

A common drug used for inflammatory skin conditions may hold the key to treating both alcohol addiction and pain sensitivity. That’s what scientists at a leading research institute have found.

Gilead's FDA-approved Yeztugo, a twice-yearly injectable HIV PrEP, showed near-perfect trial efficacy but faces backlash over its $28K annual price.

Clinical trials have shown that six-monthly injections of lenacapavir are almost 100 percent protective against becoming infected with HIV. But big questions remain over the drug’s affordability.

The FDA approved Dupixent for the treatment of adults with bullous pemphigoid, a rare skin disease often uncontrolled with systemic corticosteroids, Sanofi and Regeneron announced. The FDA’s ...

The Food and Drug Administration (FDA) has approved Yeztugo (aka. lenacapavir or LEN), a twice-a-year injection that stops HIV from replicating inside cells, thereby reducing the risk of ...

Health FDA Approves ‘Breakthough’ Drug to Prevent HIV In clinical trials, researchers found Yeztugo to be highly effective as a twice-yearly form of pre-exposure prophylaxis.

Gilead Sciences, maker of the drug, announced that a twice-a-year injection of lenacapavir has been approved in the United States for HIV prevention under the brand name Yeztugo.

Researchers from the George Washington University have uncovered promising evidence in an animal study that shows setmelanotide, an FDA-approved medication for a rare genetic obesity disorder, may ...

Garadacimab-gxii is the first and only treatment that targets factor XIIa (FXIIa) for the prophylactic prevention of hereditary angioedema (HAE) attacks in patients 12 years and older.

The U.S. Food and Drug Administration has approved George Medicines' Widaplik (telmisartan, amlodipine, and indapamide) for the treatment of hypertension in adults.

FDA leaders believe that AI can make a “first-pass” at the nearly 500,000 pages of documents included in applications received by the agency.