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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

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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

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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

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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

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

FDA-483 on IntegraDose Inspection

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FDA releases the form FDA-483 with six observations from an inspection at the Minneapolis, MN-based IntegraDose Compounding Servic...

Integra Recalls Surgical Applicators Over Sterility Issues

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Integra LifeSciences recalls (Class 1) its Extended Tip Applicators due to sterility concerns.

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.

Limited Covid Vaccines OKd for Upcoming Season

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FDA approves supplemental BLAs from Moderna and Pfizer/BioNTech for their mRNA Covid-19 vaccines that target the LP.8.1 variant of...

Amylyx Nixes AMX0035 Development After Failed Study

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Amylyx Pharmaceuticals discontinues development of its investigational therapy AMX0035 (sodium phenylbutyrate and taurursodiol) in...