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Placebo-controlled Trials Needed for Vaccines: HHS

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A self-described radical HHS policy now requires all new vaccines to be evaluated in placebo-controlled trials before theyre licen...

FDA Extends Aficamten Review Over REMS Request

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FDA extends by three months its review of a Cytokinetics NDA for aficamten for treating patients with obstructive hypertrophic car...

Satsuma Migraine Resubmitted NDA Approved

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FDA approves a Satsuma Pharmaceuticals 505(b)(2) NDA for Atzumi (dihydroergotamine (DHE)) nasal powder for the acute treatment of ...

Vanda Tradipitant Scheduling Order Out

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The FDA Office of Scientific Integrity publishes a scheduling order for Vandas request for a hearing on a proposed CDER order to d...

FDA Rehiring Some Travel Support Staff

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The Associated Press reports FDA is attempting to rehire some travel support, food scientist, and Freedom of Information Act staff...

FDA Approves Element Science Wearable Defibrillator

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FDA approves the Element Science PMA for its Jewel Patch wearable cardioverter defibrillator.

Edwards Expands SAPIEN for Asymptomatic Patients

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FDA approves Edwards Lifesciences' SAPIEN 3 transcatheter aortic valve replacement platform for patients with severe aortic stenos...

Semaglutide Wins in Steatohepatitis, Fibrosis

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A Phase 3 trial funded by Novo Nordisk showed that its Ozempic/Wegovy outperformed placebo in patients with steatohepatitis and fi...

Drug Safety Monitoring Hurt by FDA Staff Cuts: Post

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Chemistry & Engineering News reports that reductions in CDER Division of Drug Information staff are affecting FDAs ability to main...

Reopen FDA San Juan Lab: Representatives

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Reps. Alexandria Orcasio-Cortez and Nydia Velzquez ask HHS secretary Robert F. Kennedy, Jr., to reopen the FDA San Juan medical pr...