Subjecting participants to invasive procedures without the prospect of therapeutic benefit is unjustifiable,” says the CEO of ...

Agency officials promise fast reviews of new treatments while vowing they will not be a “rubber stamp” for the industry. But ...

The back-and-forth between the FDA and gene therapy developer uniQure is getting messier, with an agency spokesperson now denying the biotech’s claims about a sham trial request for the rare ...

Vinay Prasad’s exit — his second from the agency in less than a year — comes after sharp criticism of his handling of drug ...

News and commentary from the world of neurology and neuroscience ...

"The stories are so outrageous," Senator Ron Johnson said. "It just appears that they’re looking for excuses to say no." ...

The Food and Drug Administration’s head of vaccines and biotechnology drugs, Dr. Vinay Prasad, is leaving the agency as of ...

The latest firm caught between the FDA’s shifting demands for “gold standard” science and regulatory flexibility for rare disease therapies, Uniqure NV saw its shares plummet after disclosing that U.S ...

This will be Prasad’s second exit from the FDA during the current Trump administration. In July, he resigned amid his controversial handling of a gene therapy treatment for Duchenne muscular dystrophy ...

"I don't think we needed this crazy journey," the "SNL" alum says of the tumultuous lead-up to the film's long-delayed ...