A cancer drug candidate that, rightly or wrongly, became a flashpoint at FDA, fails on a second try at approval.
The second time is not the charm for Replimune’s melanoma candidate RP1. | The second time is not the charm for Replimune’s ...
Espresso Malted Milk Balls sold nationwide were recalled after undeclared wheat and soy were found. The FDA classified the ...
US regulators have withdrawn their approval of a GSK Plc drug that the Trump administration had promoted as a treatment for ...
The ​U.S. ‌Food and ​Drug ​Administration ⁠on ​Friday declined ​to approve ​Replimune's ​drug for ‌advanced ⁠skin cancer, ...
A CNBC investigation revealed the proliferation of AFPs, which import prescription drugs from overseas in what U.S.
Under the new priority voucher program (CNPV), the FDA has approved a new oral GLP-1 drug, Foundayo, offering an alternative ...
A Louisiana court on April 7 asked the FDA to complete its internal review of mifepristone’s safety and gave the agency six months to provide the court with an update on the investigation.
GSK discontinued Wellcovorin in 1999, but the FDA in September last year asked the pharma to refile an application, pointing ...
The FDA is facing criticism from the U.S. Public Interest Research Group regarding delays in its food recall process.
April 8 (Reuters) - The U.S. Food and Drug Administration has told medical device maker Medline that its syringes used in ...
A federal judge Tuesday refused to block filling prescriptions for the abortion pill mifepristone by mail across the U.S. — ...