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Royal Philips Zenition 30 Imager Cleared

[ Price : $8.95]

FDA clears a Royal Philips 510(k) for its Philips Zenition 30 mobile C-arm imaging device.

Panel to Review Colon Cancer Blood Test

[ Price : $8.95]

FDA announces that its Medical Devices Advisory Committees Molecular and Clinical Genetics Panel is scheduled to review a Guardant...

Complete Response' on Abeonas PZ-Cel BLA

[ Price : $8.95]

FDA issues Abeona Therapeutics a complete response letter on a BLA for prademagene zamikeracel (pz-cel), requesting additional inf...

Par Recalls 7 Treprostinil Lots

[ Price : $8.95]

Endos Par Pharmaceutical recalls seven lots of treprostinil injection 20g/20mL due to the potential for the presence of silicone p...

Info Collection on FDA Social/Behavioral Research

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection extension entitled Data To Support Social and Behavioral ...

PhRMA Wants More Feedback on Innovative Trials

[ Price : $8.95]

Pharmaceutical Research and Manufacturers of America urges FDA to hold more meetings on innovative clinical trial approaches to al...

Draeger Recalls Perseus Anesthesia Device

[ Price : $8.95]

Draeger Medical recalls its Draeger Perseus A500 Anesthesia Workstation due to the potential for an unexpected shutdown while oper...

Boxed Warning Ordered on CAR T-Cell Therapies

[ Price : $8.95]

FDA orders a Boxed Warning to highlight the serious risk of T cell malignancies following administration of BCMA-directed or CD-19...

Cochlear Osia Cleared for Younger Children

[ Price : $8.95]

FDA clears a Cochlear 510(k) to lower the patient age for its Cochlear Osia System from 12 years to five years for children with c...

Alvotech/Tevas Stelara Biosimilar Approved

[ Price : $8.95]

FDA approves Alvotech and Teva Pharmaceuticals Selarsdi (ustekinumab-aekn) injection for subcutaneous use, a biosimilar to Johnson...