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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 ...

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Biologics

BMS Files sBLA for Breyanzi Expanded Use

FDA accepts for priority review a Bristol Myers Squibb supplemental BLA for Breyanzi (lisocabtagene maraleucel) to expand its current indication to in...

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Medical Devices

FDA De Novo for Owlet Dream Sock

FDA grants Owlet a de novo marketing authorization for its Dream Sock, an over-the-counter medical pulse oximetry solution for infants.

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Human Drugs

Samsung Seeks Interchangeable Humira Biosimilar

FDA accepts for review a Samsung Bioepis supplemental BLA that seeks an interchangeability designation for its Hadlima (adalimumab-bwwd) injection 40 ...

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Marketing

Brochure Overstates Phexxi Benefits: OPDP

An FDA untitled letter cautions Evofem Biosciences that a promotional brochure for its on-demand contraceptive Phexxi overstates the products benefits...