News

Bay Area family shares frustrations after FDA rejects drug for ultra-rare Barth Syndrome
With the FDA recently rejecting a drug application that aims to help those living with Barth Syndrome, one Bay Area family is ...
US FDA eliminates risk evaluation, mitigation strategies for CAR-T cancer therapies
The U.S. Food and Drug Administration said on Friday it had eliminated risk evaluation and mitigation strategies (REMS), a ...
BioSpace2d
Novavax Approval Process a Potential ‘Harbinger’ of Threat to FDA Integrity: Former Regulators
Writing in JAMA, four former government officials warn that the Trump administration’s involvement in delaying the approval ...
Seven Things to Know About ProPublica’s Investigation of the FDA’s Secret Gamble on Generic Drugs
ProPublica spent 14 months investigating the FDA’s oversight of foreign drugmakers that send medications to the U.S. These ...
FDA probes deaths of boys taking Sarepta Duchenne drug
The FDA said yesterday that it is investigating the deaths from liver failure of two non-ambulatory boys with Duchenne ...
FDA-approved drug may also treat alcoholism and withdrawal pain
A common drug used for inflammatory skin conditions may hold the key to treating both alcohol addiction and pain sensitivity.
US FDA Eliminates Risk Evaluation and Mitigation Strategies for CAR-T Cancer Therapies
(Reuters) -The U.S. Food and Drug Administration said on Friday that it had eliminated the risk evaluation and mitigation ...
MedPage Today1d
Experts Have Questions About FDA's New Priority Review Program
While there's little disagreement that speeding drug approvals would be a good thing, there are more questions than answers ...