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Y-mAbs Therapeutics Re-filing BLA for Omburtamab

[ Price : $8.95]

Y-mAbs Therapeutics plans to re-submit a BLA on omburtamab for treating patients with CNS/leptomeningeal metastases from neuroblas...

Pfizer Delays Covid Vaccine in Infants

[ Price : $8.95]

Pfizer and BioNTech delay their rolling BLA for an amended Emergency Use Authorization for the Covid-19 vaccine to include young c...

FDA Clears Esaote Open MRI System

[ Price : $8.95]

FDA clears an Esaote North America 510(k) for its Magnifico Open MRI, a whole-body MRI system.

FDA Grants EUA for Lilly Monoclonal Antibody

[ Price : $8.95]

FDA grants Eli Lilly an emergency use authorization for its monoclonal antibody bebtelovimab and its use in treating Covid-19, inc...

Taiho Oncology Wants Restrictions on Generic Lonsurf

[ Price : $8.95]

Taiho Oncology asks FDA to not allow applicants for generic Lonsurf to carve out labeling information from a dedicated Taiho renal...

Ardelyx Continuing Tenapanor Appeal

[ Price : $8.95]

Ardelyx says it is appealing to the FDA Office of New Drugs an appeal denied letter on its tenapanor NDA.

Califf Nomination Vote Moving to Senate Floor

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Senate majority leader Chuck Schumer files cloture on FDA commissioner-nominee Robert Califfs nomination, which will likely send i...

Draft Guide on Non-Opioid Analgesics

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Federal Register notice: FDA makes available a draft guidance entitled Development of Non-Opioid Analgesics for Acute Pain.

Put Conditions on Injectafer sNDAs: Petition

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The Axinn law firm asks FDA to put conditions on any approval of Injectafer sNDAs based on three clinical trials the firm says hav...

Patent Infringement Notice on Alvotech Biosimilar BLA

[ Price : $8.95]

Federal Register notice: FDA posts a notice that biosimilar BLA applicant Alvotech has notified the agency that it has been sued f...