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FDA Approves Element Science Wearable Defibrillator

[ Price : $8.95]

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

Edwards Expands SAPIEN for Asymptomatic Patients

[ Price : $8.95]

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...

Immunic Reports Positive Data on MS Drug

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Immunic reports positive data from its Phase 2 CALLIPER trial of nuclear receptor related 1 activator vidofludimus calcium (IMU-83...

Gilead Pays $202 Million Over Kickbacks Scheme

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Gilead Sciences agrees to pay $202 million to resolve claims that the company offered and paid kickbacks (e.g., honoraria payments...

Makary Suggests Raising Bar on Covid Boosters

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FDA commissioner Marty Makary suggests more data could be required for Covid-19 vaccine boosters this winter.

Little Trust in New Health Leaders: Poll

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A poll from the Harvard University T.H. Chan School of Public Health finds that more Americans say they will be trusting public he...

FDA Layoffs Affect Product Development: Post

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Skadden attorneys say the FDA reduction in force should have the greatest negative impact on products that are in development.