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Ambu Recalls its SPUR II Resuscitators

[ Price : $8.95]

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

[ 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

[ Price : $8.95]

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

[ Price : $8.95]

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

Complete Response on Telix PET Imaging Agent

[ Price : $8.95]

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

FDA Rejects Outlooks Wet AMD Drug Again

[ Price : $8.95]

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

AdventaPharma Wants Generic Ozempic Conditions

[ Price : $8.95]

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

Bayer NDA Accepted for Next-Gen Contrast Agent

[ Price : $8.95]

FDA accepts Bayers NDA for gadoquatrane, a next-generation gadolinium-based contrast agent for use in magnetic resonance imaging.

Sen. Cassidy Seeks Postponement of Vaccine Panel

[ Price : $8.95]

In the wake of CDC director Susan Monarezs firing, Senate HELP Committee chair Bill Cassidy (R-LA) calls on HHS to postpone a just...

FDA Recommends More Leqembi MRIs

[ Price : $8.95]

FDA says it is requiring a change in labeling for Eisai/Biogens Alzheimers drug Leqembi to call for an earlier MRI monitoring scan...