The Food and Drug Administration commissioner's effort to drastically shorten the review of drugs favored by President Donald ...

The FDA has accepted a biologics license application from Inovio for a potential treatment for adults with recurrent respiratory papillomatosis. Although the application was filed under the ...

Much is riding on Travere Therapeutics’ bid to gain an expansion for Filspari to treat focal segmental glomerulosclerosis ...

Questions remain among top Food and Drug Administration officials over who has the appropriate legal authority to sign off on ...

Less than two weeks after rejecting Sanofi’s investigational multiple sclerosis drug, the FDA has publicly shared the ...

Last month, the FDA declined to approve Sanofi’s tolebrutinib for a specific form of multiple sclerosis. In a recently ...

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 ...

WASHINGTON (AP) — The Trump administration said Tuesday it will limit approval for seasonal COVID-19 shots to seniors and others at high risk pending more data on everyone else — raising questions ...

Lizzy Lawrence leads STAT’s coverage of the Food and Drug Administration. She was previously a medical devices reporter. You can reach Lizzy on Signal at lizzylaw.53. Helen Branswell covers issues ...

ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive our biggest stories as soon as they’re published. These highlights were written by the reporters and editors ...

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 ...