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 treatment was approved in 2024 for chronic graft-vs-host disease after failure of at least 2 prior lines of systemic therapy in patients weighing at least 40kg. The Food and Drug ...

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 ...

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 ...

Johnson & Johnson's Spravato has been approved to treat a major depressive disorder in adults who have had an inadequate response to at least two oral antidepressants, the FDA announced Tuesday.

Learn more › While wax is a good way to protect your car or truck from scratches and swirls, a car paint sealant is arguably a better option. It lasts longer, and the formula is more durable ...

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 that the U.S. Food and Drug Administration has approved Spravato (esketamine ... for daily oral antidepressants." The FDA's decision followed a priority review ...

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.

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 ...