The FDA has approved Evrysdi in tablet form for patients with spinal muscular atrophy aged 2 years and older who weigh more ...

Many consumer devices undergo the FDA clearance process, such as LED masks and fitness trackers that have features like ...

The U.S. Department of Justice (DOJ) and 18 state attorneys general (AG) announced a settlement with Boston-based QOL Medical, LLC (QOL) and its ...

C&EN’s tabulation follows approvals from the FDA’s Center for Drug Evaluation and Research; therefore, it does not include blood products, gene therapies, vaccines, and other therapies that ...

Drug firm Laurus Labs Ltd on Wednesday (January 22) said its wholly-owned foreign subsidiary Laurus Generics Inc (LGI), based in Berkeley Heights, New Jersey, has received a Form 483 from the US Food ...

However, it had to be used in conjunction with an oral medication. The FDA has now expanded its approval to include the standalone use of the nasal spray for adults with treatment-resistant major ...

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, the ...

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 ...

Specifically, the change would add the selection to field D5 of FDA Forms 3500 and 3500A, which currently include options for only over-the-counter, generic, compounded and biosimilar drugs. It would ...

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.

Cipla said that the United States Food and Drugs Administration (US FDA) has issued one observation in Form 483 to the manufacturing facility of its wholly-owned subsidiary Medispray Laboratories. In ...