The Organization file

FDA

41 stories · 6 sources · updated every week

The FDA is actively shaping future healthcare, clearing new drugs for melanoma and narcolepsy, and approving Moderna's mRNA flu vaccine despite past political challenges. Watch for impacts on patient access and pricing, as well as the FDA's evolving stance on manufacturing quality (ITM rejection) and AI integration following the recent demo day.

FDA

Timeline

Ionis wins FDA approval for first Alexander disease drug

FDA Lifts Clozapine Registry, but Prescriber Fear Persists

FDA TEMPO Pilot Lets AI Devices Reach Patients Pre-Authorization

STAT+: We’re reading about drug pricing deals, a new cancer therapy approval, and more

FDA Approves Protagonist-Takeda's Mimrylo for Rare Blood Cancer

RFK Jr's IACC adopts autism plan critics call 'fringe science'

FDA Approves Roivant's Lisraya for Dermatomyositis

FDA Approves Rasonque, First Targeted Pancreatic Cancer Drug

FDA Preps New Guidance on Generative AI Devices

Senators Press RFK Jr. Over Gardasil Stake Disclosure

FDA Pauses Regenxbio Gene Therapy Trial Over Spinal Masses

FDA Plans Generative AI Medical Device Rules

FDA Lets Capricor Resubmit Deramiocel Data Post Panel Vote

Trump picks Heidi Overton to lead FDA

Regeneron's Pasatru approved for ultra-rare bone disease

Trump to Nominate Overton as FDA Commissioner

Trump to Nominate Heidi Overton for FDA Commissioner

STAT+: Government workers feel the squeeze on health care

Kratom Poison Center Cases Surge 6,500% in a Decade

Eyepoint's Duravyu Fails Phase 3 Goal, Stock Plunges

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