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Omeros Rolling BLA for Narsoplimab

[ Price : $8.95]

Omeros completes a rolling BLA submission for narsoplimab for treating hematopoietic stem cell transplant-associated thrombotic mi...

FDA Delaying BMS Liso-Cel Action Date

[ Price : $8.95]

FDA delays the PDUFA action date to complete review of a BMS BLA for liso-cel to treat some large B-cell lymphomas due to the pand...

First At Home Covid Test Gets EUA

[ Price : $8.95]

FDA grants Lucira Health an Emergency Use Authorization for the first prescription molecular diagnostic test for Covid-19 that can...

BsUFA 3 Public Meeting Looking at New Proposals

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CDER Office of Therapeutic Biologics and Biosimilars director Sarah Yim previews issues likely to be raised at an 11/19 Biosimilar...

ASCA Pilot Program Explained

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CDRH senior policy analyst Stacy Cho describes in a Webinar the thinking behind the Accreditation Scheme for Conformity Assessment...

Draft Guide on Device Electromagnetic Compatibility

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Federal Register notice: FDA makes available a draft guidance entitled Electromagnetic Compatibility of Medical Devices.

Adding CDK Inhibitors Helps Some Breast Cancer Treatment: Study

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CDER researchers say adding a CDK 4/6 inhibitor to hormonal treatment helps some metastatic breast cancer patients.

Workshop on Generic Peptide Product Immunogenicity Risks

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FDA announces a 1/26 virtual workshop on non-clinical assays for comparative immunogenicity risk assessment for generic peptide pr...

Hahn Says FDA Increasing EUA Transparency

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FDA commissioner Stephen Hahn says the agency is posting scientific review materials relating to emergency use authorization actio...

PhRMA Adds Diversity to Clinical Trial Principles

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PhRMA adds a chapter on diversity to its principles for conducting and communicating clinical trials.