After the FDA declined to approve Lykos Therapeutics’ MDMA-assisted therapy for post-traumatic stress disorder, companies are pivoting away from or delaying similar therapeutics targeting the ...

This follows cases of drug toxicity, resulting in fatalities in Central Asia, North America, and Africa. India’s ...

The Food and Drug Administration sends warning letters to entities under its jurisdiction as part of its enforcement activities. Some letters are not ...

Zydus Lifesciences has received a significant approval from the US FDA for Enzalutamide capsules, which are used in treatment ...

The withdrawal comes after postmarketing studies showed that the risks of side effects were greater than the benefits.

Certain synthetic food dyes are linked to behavioral issues in kids. Gov. Gavin Newsom signed a law to ban them in school ...

EBR Systems (ASX:EBR) announces the US FDA has accepted its final premarket approval application for the WiSE CRT System.

Certain synthetic food dyes are linked to behavioral issues in kids. Gov. Gavin Newsom signed a law to ban them in school ...

Ongoing shortages of popular weight loss and diabetes drugs in the U.S. have spurred fierce competition between established drugmakers and an emerging market of compounded versions as telehealth ...

In addition to Pfizer and Moderna's new formulas, Novavax's protein-based shot is an option for COVID vaccination this season ...

Apple Watch sleep apnea feature approved in Canada and US. Detects breathing disturbances during sleep using wrist movements.