The FDA has approved Amneal Pharmaceuticals’ ( NASDAQ: AMRX) OTC Naloxone HCl nasal spray, a generic version of the opioid ...
By Chris Wack Amneal Pharmaceuticals shares were up 9% after the Food and Drug Administration approved an abbreviated new drug application ...
(RTTNews) - Amneal Pharmaceuticals, Inc. (AMRX) announced on Wednesday that it has received FDA approval for its Over the Counter ... Nasal Spray is a generic version of the widely used OTC NARCAN HCI ...
Instead, Galiatsatos said, the FDA approved the drug based on other signs of effectiveness, including whether patients were able to walk farther in six minutes than they could before they started ...
MORE: FDA approves the active ingredient in Mounjaro to help people with obesity lose weight, named Zepbound Wegovy, like Zepbound, is FDA-approved for weight loss. Its main ingredient is ...
The approval makes ravulizumab the first and only long-acting C5 complement inhibitor for this indication and is supported by data from the phase 3 CHAMPION-NMOSD trial (NCT04201262), published in ...
Due to adcomm panel meet, the FDA pushed the approval date for Abecma from 16 December 2023. Abecma helped extend the time before disease progression by 13.3 months vs. 4 months in standard care ...
Instead, Galiatsatos said, the FDA approved the drug based on other signs of effectiveness, including whether patients were able to walk farther in six minutes than they could before they started ...