Pfizer Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted full approval to BRAFTOVI® (encorafenib) in combination with cetuximab (marketed as ERBITUX®) and ...

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 ...

At an event on Monday, the agency officially unveiled long-awaited draft guidance meant to help speed the development of bespoke treatments for extremely rare diseases.

U.S. Food and Drug Administration Commissioner Marty Makary on Monday defended his agency's position and record on mRNA vaccines, days after it changed course and agreed to review a Moderna flu ...

A new investigation has found irregularities in the ethics review of a grant to study effects of a birth dose of hepatitis B vaccine in Guinea-Bissau.

The discount program targets a specific group of Americans. Find out if you're one of them.

The US Food and Drug Administration has refused to accept an application from Moderna to review its first mRNA seasonal flu vaccine, the company said Tuesday, in another setback for the technology ...

The Trump administration has rolled out a new website called TrumpRx, aimed at offering consumers lower prices on certain prescription drugs. The site, launched last week, lists discounted medications ...

A version of this article first appeared in CNBC's Healthy Returns newsletter, which brings the latest health-care news straight to your inbox. Subscribe here to receive future editions. Pfizer made ...

Pfizer (PFE) announced on Friday that the U.S. Food and Drug Administration granted priority review for a marketing application seeking a label expansion for its hemophilia therapy, Hympavzi. The New ...

Pfizer has won U.S. Food and Drug Administration priority review for its application seeking expanded approval of its Hympavzi hemophilia drug for two patient populations with significant medical need ...