We’ve launched a first-of-its-kind app to help you find out where your generic drugs come from and see the track records of ...
The US Food and Drug Administration will take steps to streamline the development of generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to accelerate ...
Six weeks after a reduction in force (RIF) at the US Food and Drug Administration removed thousands of workers, signs are emerging about how the agency’s approach to drug approval may change. The 20% ...
The FDA granted Priority Review to the supplemental New Drug Application (sNDA) for lurbinectedin in combination with atezolizumab as a first-line maintenance treatment for patients with ...
The US Food and Drug Administration’s longtime oncology chief has filed to retire from the agency just weeks after he was chosen to lead the FDA’s drug division, according to four people familiar with ...
Since 2022, four GLP-1 drugs, including those indicated for weight loss, have been on FDA’s drug shortage list due to extraordinarily high patient demand. The shortage has, in turn, resulted in ...
April 10 (UPI) --The U.S. Food and Drug Administration is replacing animal testing with human-relevant methods, including artificial intelligence, when developing monoclonal antibody therapies and ...
Generic drugs are supposed to be equivalent to brand-name medications — but the FDA doesn’t always ensure that.
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