For decades, the Food and Drug Administration has been notoriously tight-lipped about why it rejects drugs. It has remained all-but-silent even when the agency rejects the advice of its advisory ...

Replimune Group's RP1 oncolytic virus therapy faced an FDA rejection, raising concerns about the platform's viability in ...

One of the most notable accomplishments of the first Trump Administration was its willingness to take on the status quo of ...

GoodRx reports that in 2025, novel drug and biosimilar approvals lag slightly behind last year, while first generic approvals are ahead.

CMS often withholds coverage for reimbursement, disrupting the natural flow of the market and hindering access to proven ...

Shares of Replimune Group Inc. (NASDAQ:REPL) plunged 36% in premarket trading after a report revealed new details about the ...

The FDA recently unveiled a new national priority voucher program that would seek to trade faster drug approvals for lower ...

FDA Commissioner Marty Makary said at a press conference Tuesday that the federal government is beginning to process to ...

According to WSJ, the FDA used this process to review 99 percent of about 3,000 medical device applications in 2013. In 2011, a panel at the Institute of Medicine called for the recreation of the ...

With vaccine approval process set to change, FDA advisers leave wiggle room in annual Covid-19 shot recommendations By Brenda Goodman, CNN May 23, 2025 Updated May 23, 2025 0 ...

In a letter to 93 manufacturers, Jeffrey Shuren, MD, director of the FDA's Center for Devices and Radiological Health, wrote that the agency was acting to reduce the number of underdoses ...

The FDA advisory committee heard evidence from vaccine manufacturers that vaccination with JN.1-or KP.2-based shots continues to boost antibodies to protective levels, even against newer viruses ...