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 ...
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 ...
On April 3, the FDA approved Zevtera, an antibiotic with three different uses. The medication is indicated for adults with Staphylococcus aureus bloodstream infections, including right-sided ...
The U.S. Food and Drug Administration (FDA) has approved a new type of medicine for people who aren’t able to control their high blood pressure with other drugs. Tryvio (aprocitentan ...
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 ...
The US Food and Drug Administration has approved a fusion protein made by Merck & Co. for a rare, life-threatening lung disorder. The drug, called sotatercept and set to be marketed under the name ...
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 ...
When doctors told Katrina Barry that she had a rare and serious condition called pulmonary arterial hypertension or PAH, they warned her not to Google it. Come on, she thought; they wanted a young ...