Add Yahoo as a preferred source to see more of our stories on Google. More than 650,000 bottles of water distributed in Illinois and Wisconsin were recalled in late February after the U.S. Food and ...

A Boehringer Ingelheim drug now has FDA approval as an earlier treatment for lung cancers expressing a certain genetic signature, a regulatory decision handed out under the agency’s new pilot program ...

Please provide your email address to receive an email when new articles are posted on . A supplemental new drug application seeks to expand the indication for Ryzumvi. The solution was originally ...

Approval covers adults and children ≥6 years with prior sinonasal surgery, representing the first FDA-cleared pharmacologic option specifically for AFRS and dupilumab’s ninth U.S. indication.

Federal health officials on Monday laid out a proposal to spur development of customized treatments for patients with hard-to-treat diseases, including for rare genetic conditions that the ...

Vanda Pharmaceuticals is riding a regulatory roller coaster over the last few months. December brought an FDA thumbs up for its new motion sickness drug Nereus. Then in January, the U.S. regulator ...

The FDA has released draft guidance outlining an approval pathway for individualized therapies aimed at ultra-rare diseases, building on a framework first outlined by agency leaders in November. The ...

The Food and Drug Administration plans to drop its longtime standard of requiring two rigorous studies to win approval for new drugs, the latest change from Trump administration officials vowing to ...

Moderna said the Food and Drug Administration has agreed to review its experimental mRNA flu shot, reversing an earlier decision to refuse to accept the application. The FDA is slated to make a ...

The Food and Drug Administration will review Moderna’s new flu vaccine after initially refusing to review the candidate, the Cambridge biotech announced early Wednesday. The FDA’s decision not to ...

The U.S. Food and Drug Administration will review a messenger RNA (mRNA) flu vaccine for approval, according to its maker, Moderna. The decision is a dramatic U-turn for the agency, which, only about ...

The Food and Drug Administration has refused to review Moderna's application for its seasonal flu vaccine, the company announced on Feb. 10, marking the latest setback for the development of ...