FDA staffers and outside experts worry the program runs afoul of legal, ethical and scientific standards used to review new ...

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

Food and Drug Administration has delayed reviews of two drugs chosen for the Trump administration's new fast-track program ...

The Food and Drug Administration has announced some major changes to the review process for drug developers in the United States. It could cut down the time from 10 to 12 months for a review to just ...

In early 2025, the FDA was rocked by sweeping layoffs and leadership turnover, raising questions about whether the agency ...

On June 17, 2025, the U.S. Food and Drug Administration (FDA) announced the Commissioner’s National Priority Voucher (CNPV) program, a new program that aims to speed up drug application review for ...

FDA delayed fast-track reviews for multiple drugs after safety and efficacy concerns, including adverse events and a reported ...

The FDA is launching a National Priority Voucher program to accelerate reviews of certain new drug applications. The agency will distribute a limited number of vouchers in the program’s first year to ...

MALMÖ, SE / ACCESS Newswire / November 15, 2025 / Ascelia Pharma AB (publ) (ticker: ACE), a biotech focused on improving the life of people living with rare cancer conditions, today announced that the ...

If approved, avutometinib in combination with defactinib would be the first-ever FDA-approved treatment specifically for adults with recurrent KRAS mutant LGSOC “The FDA filing acceptance and Priority ...

Takeda and Protagonist Therapeutics have submitted a new drug application to the FDA for rusfertide for adults with ...

The US Food and Drug Administration (FDA) has granted Fast Track Designation to Complement Therapeutics’ CTx001, the ...