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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 ...

Replimune takes third swing at cancer drug approval following ‘productive’ FDA talks

A twice-spurned therapy that’s been seen as one of the FDA’s more controversial recent rejections is getting a new chance ...

FDA Acting Head to Meet Closed-Door With Rare Disease Groups (1)

The FDA is scheduled to have a closed-door roundtable this week with over a dozen groups advocating for rare disease ...
MedPage Today

Speeding Up Approvals, Getting More Drugs OTC Among FDA's Top Priorities

The FDA is continuing its quest to speed up drug approvals and make more drugs available over the counter (OTC), FDA Commissioner Marty Makary, MD, MPH, said Wednesday. "We want to challenge the ...
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 ...