President Trump’s nominees to head the National Institutes of Health (NIH) and Food and Drug Administration (FDA) cleared a key Senate committee largely along party lines Thursday, paving the way for ...

The U.S. Food and Drug Administration’s Medical Devices Advisory Committee Microbiology Panel unanimously voted that Roche Molecular Systems’ cobas viral DNA test is safe and effective as a ...

At age 45, Dr. Lakiea Bailey said, for the longest time, that she was the oldest person with sickle cell anemia that she knew. The executive director of the nonprofit patient advocacy group the Sickle ...

“What’s that? (I may be paranoid, but no android),” Radiohead once sang. That familiar tension between human judgment and technology echoes strong in today’s debate about artificial intelligence (“AI” ...

The Food and Drug Administration abruptly canceled its advisory committee meeting, which is tasked with recommending the composition of annual flu shots. The Vaccines and Related Biological Products ...

Please provide your email address to receive an email when new articles are posted on . The meeting was scheduled for March 13. The FDA said it will make recommendations to manufacturers in time for ...

The Food and Drug Administration commissioner's effort to drastically shorten the review of drugs favored by President Donald ...

FDA leaders under President Trump are moving to abandon a decades-old policy of asking outside experts to review drug applications, a move critics say would shield the agency's decisions from public ...

Capricor Therapeutics Inc (NASDAQ:CAPR) on Tuesday provided regulatory updates related to its Biologics License Application (BLA) for Deramiocel, the company’s lead cell therapy candidate for the ...

Date and FDA Advisory Committee: February 2, 2004 Joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee ...