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FDA Accepts Coherus Bio BLA for Humira Biosimilar

[ Price : $8.95]

FDA accepts for review a Coherus BioSciences BLA for CHS-1420, a biosimilar to AbbVies Humira (adalimumab).

Nymalize Not Withdrawn Due to Safety/Efficacy: FDA

[ Price : $8.95]

Federal Register notice: FDA determines that Arbor Pharmaceuticals Nymalize (nimodipine) oral solution was not withdrawn from sale...

CellTrans BLA Goes Before Advisory Committee

[ Price : $8.95]

Federal Register notice: FDA announces a 4/15 meeting of its Cellular, Tissue and Gene Therapies Advisory Committee to discuss a C...

FDA Looking for Ways to Help Cancer Therapies Evolve Safely

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CBER director Peter Marks says FDA is finding ways to encourage the timely evolution of cancer therapies while still having enough...

Supplement Company Owner Sentenced in Steroid Case

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The Justice Department says sports supplement company owner Brian Parks was sentenced to time in prison and forfeited $350,000 for...

5 Provisions in FDA Artificial Intelligence/Machine Learning Plan

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Attorney Matthew Decker outlines five key provisions of an FDA action plan on the regulation of artificial intelligence and machin...

Bluebird Bio Suspends 2 Gene Therapy Studies

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Bluebird Bio temporarily suspends studies of LentiGlobin gene therapy for sickle cell disease due to a reported unexpected serious...

FDA, DARPA Push Trustworthy Hardware

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FDA cybersecurity advisor Jessica Wilkerson urges security controls wherever they can be built into hardware and software.

Joint Panel to Review Pfizer Osteoarthritis BLA

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Federal Register notice: FDA has announced a 3/24 joint meeting of the Arthritis and the Drug Safety and Risk Management Advisory ...

Vaccines Panel to Discuss Influenza Seasonal Strains

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Federal Register notice: FDA announces a 3/5 Vaccines and Related Biological Products Advisory Committee meeting to discuss 2021 t...