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CGMP Issues at Compounders International

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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

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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

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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

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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

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

Ambu Recalls its SPUR II Resuscitators

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

Platinum Biologics Selling Unapproved New Drugs: FDA

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FDA warns Orlando, FL-based Platinum Biologics that it is illegally marketing unapproved new drugs.