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 ...
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 ...
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 ...
Hoodline13h
Attorney General Kris Mayes Leads Charge Against FDA Over Toxic Baby Food, Demands Immediate Action to Protect Children
Attorney General Kris Mayes urged the FDA to enact regulations to protect children from heavy metals in baby foods.
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 ...
Fierce Pharma3d
FDA investigates patient deaths after treatment with Sarepta's Duchenne gene therapy Elevidys
In one of the first major tests of the new FDA leadership’s regulatory philosophy toward gene therapies for rare diseases, ...
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.
MedPage Today2d
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 ...