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 ...

Jan 21 (Reuters) - The U.S. Food and Drug Administration expanded approval for Johnson & Johnson's (JNJ.N), opens new tab nasal spray, Spravato, to allow it to be used as a standalone treatment ...

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 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 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 ...

Omvoh's approval provides a new treatment option for Crohn's disease patients, especially those unresponsive to existing therapies. The FDA granted approval to Eli Lilly and Company’s ...

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 ...

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 ...

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 ...

The Food and Drug Administration approved Eli Lilly’s weight-loss drug Zepbound on Dec. 27 to treat sleep apnea, a common but potentially serious sleep-related breathing disorder, making it the ...