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Ublituximab and Umbralisib BLA for Lymphocytic Leukemia

[ Price : $8.95]

TG Therapeutics begins a rolling BLA submission for ublituximab in combination with umbralisib as a treatment for patients with ch...

SARS-CoV-2 Reference Panel Updated

[ Price : $8.95]

FDA publishes the latest update to the SARS-CoV-2 reference panel of standardized samples.

FDA Approves Vanda for Rare Sleep Disorder

[ Price : $8.95]

FDA approves a Vanda Pharmaceuticals NDA for Hetlioz (tasimelteon) capsule and liquid formulations for treating adults and childre...

Advisory Panel to Discuss Moderna Covid Vaccine 12/17

[ Price : $8.95]

Federal Register notice: FDA announces a 12/17 advisory committee meeting to discuss an emergency use authorization request by Mod...

FDA Posts 5 Info Collections Approved by OMB

[ Price : $8.95]

Federal Register notice: FDA posts five information collections that have been approved by OMB.

FDA Approves Blueprints Gavreto for Some Thyroid Cancers

[ Price : $8.95]

FDA approves a broader indication for Blueprint Medicines Gavreto to treat some thyroid cancers.

West Coast Nuclear Pharmacy Compounding Issues

[ Price : $8.95]

FDA warns West Coast Nuclear Pharmacy about drug compounding violations and drugs produced or held in insanitary conditions.

Use of Transport Media in Pandemic Q&A

[ Price : $8.95]

FDA publishes questions and answers on developing and using transport media during the Covid-19 pandemic.

Fujirebio Diagnostics 510(k) for Alzheimers Diagnostic

[ Price : $8.95]

Fujirebio Diagnostics files a 510(k) for the Lumipulse G β-Amyloid Ratio (1-42/1-40) in vitro diagnostic test for use in asse...

Transcript of Device User Fee Meeting

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FDA posts a transcript from a 10/27 CDRH public meeting on reauthorizing the Medical Device User Fee Act program that outlined age...