In the summer of 2017, Phish lit up Madison Square Garden with a historic 13-night run. Your friends at Budding Trends believe the ...

Outlook Therapeutics has notched a win in its uphill battle to commercialize an ophthalmic version of Roche’s Avastin ...

The FDA has set a target action date of November 27 for BBP-418’s new drug application in limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9) and is not planning to hold an advisory committee ...

The resignation ends Dr. Marty Makary's management of the Food and Drug Administration, which was marked by turmoil and controversy.

Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has begun piloting a fast-track registration pathway for products authorized in the European Union or United States.

NPR's Leila Fadel asks Mitch Zeller, former director of the FDA's Center for Tobacco Products, about the agency's approval of fruit-flavored electronic cigarettes.

Ensitrelvir is an investigational oral antiviral under FDA review for the prevention of COVID-19 following exposure to an infected individual. It is designed to suppress the replication of SARS-CoV-2 ...

New 'live trials' could shave years off the time it takes for new drugs to get to patients. HealthDay News — The U.S. Food and Drug Administration (FDA) is moving to speed drug development and review ...

This shift aims to turn the traditional, stop-and-go process of drug testing and reporting into a continuous stream of live data. HealthDay News — The US Food and Drug Administration (FDA) is moving ...

The first-of-its-kind pilot could lead to speedier regulatory approval of medical drugs and devices and potentially reduce “20, 30, 40% of overall clinical trial time,” according to FDA Chief ...

The U.S. Food and Drug Administration launched a pilot program on Monday aimed at allowing the agency to monitor clinical trial data in real time, a step the agency said could cut ‌years from drug ...