The U.S. Food and Drug Administration on Tuesday declined full approval for Intercept Pharmaceuticals' liver disease drug, ...
The FDA announced a proposal to remove oral phenylephrine – a common ingredient in many popular over-the-counter ...
Compounded versions of semaglutide, the active ingredient in approved diabetes and obesity drugs Ozempic and Wegovy, have ...
The FDA informed Intercept that it is unable to approve the sNDA in its current form, consistent with the outcome of the Gastrointestinal Drugs Advisory Committee (GIDAC) meeting in September 2024. In ...
GNSC-001 is an investigational, adeno-associated virus gene therapy expressing an optimized form of IL-1Ra. The Food and Drug Administration (FDA) has granted Fast Track designation to GNSC-001 for ...
LEMSIP and other popular cold and flu tablets should be pulled from Britain’s shelves because they don’t work, experts have ...
Costco recalled nearly 80,000 pounds of store-brand butter last month because the product's label was missing a key ...
FDA moves to pull nasal decongestant in some cold medicines from shelves amid effectiveness concerns
The US Food and Drug Administration announced a proposal to remove oral phenylephrine - a common ingredient in many popular ...
The FDA Modernization Act of 1997 established the Fast Track designation to expedite developing and reviewing new drugs ...
In the wake of the biggest American political comeback in more than 100 years, stakeholders in the health industry are asking themselves: What ...
The FDA updated GLP-1 drug labels to warn of the risk of patients breathing food into their lungs while under anesthesia for ...
(AskBio), a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, today announced that AB-1003 (also known as LION-101) has received rare pediatric disease ...
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