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.

Food and Drug Administration Commissioner Marty Makary said approving drugs for human consumption is moving at a “record” ...

Accelerated approval may be a worthwhile option for sponsors looking to get a product on the market and into patients' hands as soon as possible, but it is far from foolproof. If FDA's decision on ...

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

Americans rely on the Food and Drug Administration to make sure that medical devices are safe. Reporting by KFF Health News has raised questions about how the FDA has dealt with some products ...

The appeals court left intact the FDA’s initial approval of mifepristone. But it would reverse changes regulators made in 2016 and 2021 that eased some conditions for administering the drug.

The Food and Drug Administration (FDA) has approved a manufacturing process change for Yescarta ® (axicabtagene ciloleucel) allowing for a shorter manufacturing time. Yescarta, a CD19-directed ...

Once the MOU expires, FDA will use a new animal food ingredient consultation process, or AFIC, while also evaluating its animal food additive petition and generally recognized as safe, or GRAS ...