AngelNV winner Regara can cut lengthy FDA approval process in half

It takes about 14 years to get a new drug approved by the Food and Drug Administration. That leaves drug companies about six years of exclusive sales until their 20-year patent expires, and they ...
Fierce Biotech

Makary’s FDA reforms ‘continue to move forward’ despite leadership turmoil

As the FDA adjusts to life without Marty Makary, M.D., Fierce has learned that the numerous policy reforms he put in motion ...
Scientific American

RFK, Jr., puts psychedelics on fast track to FDA review and approval

The U.S. Food and Drug Administration is seeking to accelerate the review process for three companies that are studying psilocybin and an MDMA-like drug as treatments for depression and PTSD ...
Labroots

How CLSI Standards Help Manufacturers Navigate FDA Regulatory Approval with Confidence

For manufacturers, medical device companies, and laboratories that use the commercial diagnostic tests they produce, ...
Los Angeles Business Journal

Atara Bounces Back with FDA

Thousand Oaks-based Atara Biotherapeutics reaches an agreement with the U.S. Food and Drug Administration regarding the approval process for its lead drug platform. Atara Biotherapeutics' headquarters ...

The FDA has approved the sale of fruit-flavored vapes. What's behind the shift?

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.