FDA Commissioner Dr. Marty Makary discusses the crackdown on GPL-1 drugs and Moderna's new mRNA flu vaccine on 'Mornings with Maria.' ...

A challenging public health policy landscape under health secretary Robert F. Kennedy has vaccine makers rethinking ...

Reversing its initial decision, the FDA has agreed to review Moderna’s messenger RNA-based influenza vaccine for approval, the company announced Wednesday. The reversal about weeks after the FDA sent ...

FDA reverses course, will review Moderna’s new mRNA flu vaccine.

The CDC’s Advisory Committee on Immunization Practices (ACIP) will push out its February vaccine confab to an undetermined date next month, Bloomberg reported Thursday, citing an unnamed person close ...

The Food and Drug Administration plans to drop its longtime standard of requiring two rigorous studies to win approval for new drugs.

Makary helms the FDA in the midst of a contentious stretch for the agency, defined by massive staff and budget cuts and sweeping changes to vaccine policy.

Politico has reported that the White House isn’t happy with the FDA’s recent actions surrounding vaccines, fueling public scrutiny of internal decision-making at the regulator. | Politico has reported ...

The U.S. Food and Drug Administration (FDA) said it will not review Moderna’s application for the first mRNA-based flu shot.

The Food and Drug Administration agreed Wednesday to review Moderna’s application to make a new seasonal flu shot available, after initially refusing to do so. The back-and-forth reveals increased ...

Moderna, the Cambridge drug company, said Food and Drug Administration officials have changed course and decided to review its new mRNA flu vaccine. Last week, FDA officials said they were rejecting ...

Turning to market access, Eli Lilly has entered a $100 million licensing agreement with CSL Limited for clazakizumab. While CSL maintains the rights for kidney-related cardiovascular trials, Lilly ...