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2 Interchangeable Eylea Biosimilars Approved

[ Price : $8.95]

FDA approves two BLAs for interchangeable biosimilars to Regenerons Eylea (aflibercept) Biocon Biologics Yesafili (aflibercept-jb...

Meditrina 2nd Gen Hysteroscopy System Cleared

[ Price : $8.95]

FDA clears a Meditrina 510(k) for its second generation bipolar radiofrequency Aveta Glo hysteroscopy system.

FDA Discusses Future of Clinical Research

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FDA chief medical officer Hilary Marston discusses the future of clinical research and new initiatives to support clinical trial i...

Hold Removed on Friedreichs Ataxia Therapy

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FDA removes a partial clinical hold on Larimar Therapeutics nomlabofusp (CTI-1601), which is being evaluated for treating patients...

AdvaMed Seeks More Efficient Feedback Requests

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The Advanced Medical Technology Association says FDAs new draft guidance on Requests for Feedback and Meetings for Medical Device ...

EUAs Revoked for 2 Covid Tests

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Federal Register notice: FDA announces the revocation of the emergency use authorizations issued to Bio-Rad Laboratories for the B...

Product-Specific ANDA Guidances Available

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Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances that provide recommenda...

Complete Response on Liver Cancer Combo

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FDA issues Elevar Therapeutics and its Chinese partner, Jiangsu Hengrui Pharmaceuticals, a complete response letter for their comb...

FDA Clears Implicity Heart Failure Algorithm

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FDA clears an Implicity 510(k) for its algorithm SignalHF used in its remote monitoring for heart failure.