FDA commissioner Marty Makary said it would be “magical” for consumers to see prescription drugs on pharmacy shelves instead ...

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

This is eight fewer than the FDA, which approved 46 novel drugs in 2025 – sneaking in two regulatory decisions during the ...

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

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

All 16 drug companies that inked deals with the Trump administration over the past few months still raised some of their ...

More than half a dozen major drugmakers are participating in the Trump administration's speedier review program for new medicines, yet other leading pharmaceutical companies are hesitating over what ...

The FDA says it is hiring more than 1,000 new employees and rolling out a pilot communication program in an effort to speed up the review of new drugs. “FDA announced over 40 job announcements for ...

The U.S. Food and Drug Administration (FDA) has granted full approval of Laverdia, a drug to treat dogs with lymphoma, a type ...

Lizzy Lawrence spoke with more than 20 current and former FDA staff, interviewed legal experts, and reviewed agency documents to report this story. Lizzy Lawrence leads STAT’s coverage of the Food and ...

When Apellis Pharmaceuticals (APLS) secured FDA approval for EMPAVELI in C3 glomerulopathy and IC-MPGN last summer, the stock was trading near $28. Today it sits at $19.96, down 31% over the past year ...