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Medical Devices

Hamilton Recalls Defective Coaxial Breathing Sets

Hamilton Medical recalls (Class 1) certain lots of coaxial breathing sets due to a quality issue involving a defective blade in the tube-cutting stage...

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Biologics

Alzheimers Therapy Gets At-Home Injection Approval

FDA approves an Eisai/Biogen at-home injection option for Alzheimers treatment Leqembi (lecanemab), expanding access to patients in the early stages o...

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Human Drugs

Foresee Pharmas 3-Month Camcevi Formulation OKd

FDA approves a Foresee Pharmaceuticals NDA for Camcevi ETM (leuprolide mesylate), a once every three-month injectable formulation for treating advance...

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Human Drugs

J&J Kills Nipocalimab Plus Tumor Necrosis Factor in RA

Johnson & Johnson decides to stop development of nipocalimab in combination with an anti-tumor necrosis factor alpha therapy for rheumatoid arthritis ...

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Human Drugs

Novocure Scraps TTFields Study for Real-World Data

Novocure stops its LUNAR-4 study, a Phase 2 open-label trial testing Tumor Treating Fields together with Mercks Keytruda (pembrolizumab) in lung cance...

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Medical Devices

Medtronic Wins Expanded Use for Evolut Aortic Valve

FDA approves an expanded use for Medtronics Evolut transcatheter aortic valve replacement system, allowing implantation of a new Evolut valve inside a...

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Medical Devices

Ambu Recalls its SPUR II Resuscitators

Ambu recalls (Class 1) its SPUR II resuscitators due to the manometer port being blocked, which causes the manometer to become non-functional.

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Human Drugs

Complete Response on Telix PET Imaging Agent

FDA issues Telix Pharmaceuticals a complete response letter for its BLA seeking approval of Zircaix (89Zr-DFO-girentuximab), an investigational positr...

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Human Drugs

FDA Rejects Outlooks Wet AMD Drug Again

FDA sends Outlook Therapeutics a complete response letter on its resubmitted BLA for Lytenava (bevacizumab-vikg) for wet age-related macular degenerat...

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Human Drugs

AdventaPharma Wants Generic Ozempic Conditions

AdventaPharma asks FDA to impose conditions on ANDAs referencing Ozempic to ensure an equivalent pen injector and active pharmaceutical ingredient.