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The American Journal of Managed Care2m

FDA Recommends Sarepta Resume DMD Gene Therapy Shipments for Ambulatory Patients

Shipment of delandistrogene moxeparvovec, a gene therapy for Duchenne muscular dystrophy (DMD), will resume following a ...
Fierce Pharma33m

Vinay Prasad's exit signals FDA's probable slip toward more permissive regulation of cell and gene therapy: analyst

But this time, the unknown is hitting the industry in a different way from when Prasad was tapped to lead CBER less than ...
News Nation on MSN12h

FDA cracking down on 7-OH to avoid epidemic: Commissioner

7-OH, formally known as 7-Hydroxymitragynine, is banned in China; however, Makary found that in the Biden administration, the ...
WVTF2h

FDA action has delegate behind Virginia’s new vape law wanting more

The FDA analysis of Juul and a handful of other vape products was “potentially less harmful” when used to quit smoking ...

Trump drove firing of FDA official

The president overruled his HHS secretary and FDA chief, four people with knowledge of the decision tell POLITICO.
STAT43m

Pharmalittle: We’re reading about Prasad’s downfall at FDA, Moderna job cuts, and much more

Moderna announced layoffs affecting 10% of its workforce amid government and competitive challenges to its vaccine business ...

FDA seeks controlled substance status for potent synthetic opioid sold in gas stations

The FDA recommended classifying 7-OH as a Schedule I controlled substance due to its opioid-like effects and its use in unregulated products.

FDA commissioner predicts ‘record’ drug approvals this year

FDA Commissioner Marty Makary said the FDA’s review process will not slow down despite layoffs at the Department of Health ...