A stem cell clinic the FDA found to be operating illegally plans to appeal the agency's authority to the Supreme Court. The ...

The FDA established its accelerated approval program in 1992 to allow drugs to reach the market quickly for life-threatening ...

The US Food and Drug Administration (FDA) has granted investigational device exemption (IDE) approval for NextBioMedical's ...

An FDA optometry roundup discusses changes in drug approvals and devices used by optometric eye care professionals.

With Clearlight's Red Light Therapy Personal Tower, you can steal the spotlight with your own red carpet-worthy glow.

Eisai (ESAIY) and Biogen (BIIB) announced that the FDA has accepted Eisai’s Biologics License Application, BLA, for ...

Among the 55 novel drugs that crossed the regulatory finish line last year were notable new mechanisms of action, coming ...