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Wisconsin Pharmacal CGMP Violations

[ Price : $8.95]

FDA warns Jackson, WI-based Wisconsin Pharmacal about CGMP violations in its production of finished drugs.

FDA Waives Efficacy Studies for Stelara Biosimilar

[ Price : $8.95]

FDA agrees to accept a biosimilar application to compete with Johnson & Johnsons Stelara that does not include clinical efficacy s...

Medtronic Gets FDA Green Light for Diabetes Devices

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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

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

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...

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...