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 ...

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 ...

The deal does not include a provision to raise the debt limit. After days of heated negotiations on Capitol Hill and eleventh-hour interference from President-elect Donald Trump and his ally Elon ...

The FDA has approved a first-of-its-kind treatment for dry age-related macular degeneration (AMD), a leading cause of blindness in adults over 55.

The science of skincare continues to expand, and some of those advances have landed directly in consumers’ hands. Is that a ...

TEPOXX is the first antiviral therapy for orthopoxviruses approved by Japan's drug regulator in collaboration with the Ministry of Health, Labour, and Welfare. In partnership with Japan Biotechno ...

The FDA approved Zepbound (tirzepatide) as the first prescription medication specifically for adults with moderate-to-severe obstructive sleep apnea (OSA) and obesity. People taking Zepbound lost ...