At the highest levels of the FDA, questions remain about which officials have the legal authority to sign off on drugs cleared under the Commissioner’s National Priority Voucher program, which ...

Replimune Group Inc. REPL on Friday received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration for ...

Replimune shares fell after the FDA again rejected RP1, raising doubts about whether the company’s lead cancer therapy can ...

The Food and Drug Administration is scrutinizing the common practice of giving coronavirus and flu shots together, signaling a reversal of years of federal guidance and a broader crackdown on ...

The mHealth Regulatory Coalition (MRC) recently released “A Call for Clarity: Open Questions on the Scope of FDA Regulation of mHealth," which is a 60-page paper that focuses on two fundamental ...

WASHINGTON (AP) — The Food and Drug Administration commissioner's effort to drastically shorten the review of drugs favored by President Donald Trump's administration is causing alarm across the ...

The effort by FDA Commissioner Marty Makary, MD, MPH, to drastically shorten the review of drugs favored by President Donald Trump's administration is causing alarm across the agency, stoking worries ...

WASHINGTON (AP) — The Food and Drug Administration commissioner’s effort to drastically shorten the review of drugs favored by President Donald Trump’s administration is causing alarm across the ...