A government watchdog examining the FDA’s accelerated approval pathway has released a 32-page report (PDF) that concludes the agency’s controversial endorsement of Biogen’s failed Alzheimer ...

The U.S. Food and Drug Administration expanded approval for Johnson & Johnson’s nasal spray, Spravato, to allow it to be used as a standalone treatment for patients with severe depression ...

Johnson & Johnson has announced the FDA’s approval of a first-of-its-kind, esketamine nasal spray called Spravato for the standalone treatment of major depressive disorder (MDD), PTSD ...

The FDA approved several drugs in December for the treatment of diseases, including pancreatic adenocarcinoma, lung cancer, skin cancer and graft-versus-host disease. Throughout December, the Food and ...

The Food and Drug Administration (FDA) approved Johnson & Johnson's ketamine-derived nasal spray to help millions of U.S. patients suffering from severe depression. Spravato, approved as a ...

Subcutaneous nivolumab and hyaluronidase-nvhy is FDA-approved for adult solid tumors, offering a new administration route for PD-1 inhibitors. The phase 3 CheckMate-67T trial confirmed ...

The authorization does not mean the products are safe or “FDA approved,” however. Perspective from Johannes Thrul, PhD The FDA announced it has authorized the marketing of 20 Zyn nicotine ...

Almost exactly 10 years after the FDA’s initial FDA approval for Bristol Myers Squibb’s Opdivo as the first PD-1 inhibitor in the U.S., the agency has cleared an under-the-skin version of the ...

In a statement sent to Fox News Digital, Joshua Murdock, PharmD, pharmacy editor at GoodRx, commented on the "significant number" of already-approved medications that were approved for new uses in ...

Sequana Medical NV has announced the US FDA approval of its Alfapump system for treating recurrent or refractory ascites due to liver cirrhosis. This approval marks Alfapump as the first active ...

The FDA’s Center for Drug Evaluation and Research (CDER) approved 50 new small molecules, biologics and oligonucleotide therapeutics last year. The class of 2024 was a little smaller than that ...

FDA approves Zyn nicotine pouches, including 10 flavors, as a safer option for adult smokers. The decision marks the first FDA authorization for nicotine pouches, which are tobacco-free.