The U.S. Food and Drug Administration on Friday agreed to reconsider its recent decision barring drug compounders from ...
A rapid-fire reversal from the Food and Drug Administration has injected even more uncertainty into what was already a wild ...
Thousands of Americans are diagnosed with Type 1 diabetes every year, according to the American Diabetes Association. But a ...
Lundbeck announced Monday it would buy Longboard Pharmaceuticals in a $2.6 billion deal that sent Longboard stock to a record ...
Hims & Hers Health (HIMS) is enjoying a morning surge after the Food and Drug Administration (FDA) dropped fresh news ...
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not ...
The FDA, in a stark reversal, on Friday said it would reconsider its decision to remove Eli Lilly’s tirzepatide from its ...
The FDA has removed the following items from store shelves this September, including pet food, baby powder and Lactaid.
Office of Prescription Drug Promotion (OPDP) recently sent an untitled letter to Mirati Therapeutics for claims made by the ...
The spray, sold under the brand Neffy, is a single-dose nasal spray and is approved in adults and children who weigh 66 ...
The FDA's Tala Fakhouri discusses the agency's approach to the regulation of AI in clinical trials in a new interview.
Imricor Medical Systems (ASX:IMR) is racing through regulatory initiatives supporting new device approvals in the US and ...