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Medtronic Gets FDA Green Light for Diabetes Devices

[ Price : $8.95]

FDA clears a Medtronic 510(k) for its MiniMed 780G insulin delivery system to integrate with Abbotts Instinct continuous glucose m...

FDA Vaccines Panel Member Offit Removed

[ Price : $8.95]

HHS says FDA is removing members of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) and Childrens Hospita...

CGMP Issues at Compounders International

[ Price : $8.95]

FDA warns Castle Rock, CO-based Compounders International Analytical Laboratory about CGMP violations and deviations in its work t...

FDA Publishes OTC Drug Monograph Forecast

[ Price : $8.95]

FDA publishes the 2025 OTC drug monograph forecast showing eight items it expects to address over the next three years.

Hamilton Recalls Defective Coaxial Breathing Sets

[ Price : $8.95]

Hamilton Medical recalls (Class 1) certain lots of coaxial breathing sets due to a quality issue involving a defective blade in th...

Alzheimers Therapy Gets At-Home Injection Approval

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

Foresee Pharmas 3-Month Camcevi Formulation OKd

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

J&J Kills Nipocalimab Plus Tumor Necrosis Factor in RA

[ Price : $8.95]

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

Novocure Scraps TTFields Study for Real-World Data

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

Medtronic Wins Expanded Use for Evolut Aortic Valve

[ Price : $8.95]

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