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Human Drugs

Data Support Wegovy Positive CV Outcomes

Novo Nordisk says data from its landmark Phase 3 SELECT cardiovascular outcomes trial assessing the effects of once-weekly Wegovy showed that the drug...

Medical Devices

FDA Clears InMed.AI NeuroShield Tool

FDA clears an InMed.AI 510(k) for NeuroShield, which the company describes as an automated brain geometry-based quantifying analytics tool.

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Human Drugs

Exparel Gains Expanded Analgesic Use

FDA approves a Pacira BioSciences supplemental NDA to expand Exparels (bupivacaine liposome injectable suspension) label to include adductor canal blo...

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Medical Devices

Breakthrough Status for Brixton Coolio

FDA gives Brixton Biosciences a breakthrough device designation for its Coolio Therapy, which is intended to deliver long-lasting pain control in targ...

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Medical Devices

Covidien Recalls Stolen Video Laryngoscopes

Covidien recalls its McGrath MAC Video Laryngoscope in a move to remove stolen defective models that have been offered for sale illegally.

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Human Drugs

Neurocrine Bio Stops 2 Develoment Programs

Based on recent disappointing study data, Neurocrine Biosciences says it is stopping the development of two drugs being evaluated for treating focal o...

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Federal Register

Panel to Mull Multi-Cancer Detection Tests

Federal Register notice: FDA announces an 11/29 advisory committee meeting to discuss multi-cancer detection IVDs.

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Human Drugs

Consent Decree Against Drug Distributor

The Puerto Rico federal court enters a consent decree requiring Droguera Betances, one of the territorys largest pharmaceutical distributors, to pay $...

Biologics

Covid Broke Vaccine Reporting System: BMJ

A BMJ investigation raises concerns that the federal governments vaccine adverse event system is not operating as planned and safety signals are likel...

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Biologics

FDA OKs Chikungunya Vaccine

FDA approves a Valneva Austria BLA for Ixchiq, a vaccine for preventing chikungunya in individuals aged 18 years and above who are at heightened risk ...