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 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 ...
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.
Fierce Pharma2d
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 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 ...
BioPharma Dive16h
FDA takes major step to ease access to CAR-T therapy
The agency removed some onerous requirements for the complex cancer drugs and reduced restrictions on patients’ ...
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 ...
Fierce Pharma17h
FDA removes CAR-T access barrier in move set to boost cancer immunotherapy uptake
Restricted availability under an FDA-mandated drug safety program has limited the reach of CAR-T cell therapies for certain blood cancers—until now. | The FDA has removed the REMS requirements for ...