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Panel to Discuss Next Seasons Flu Shot

[ Price : $8.95]

Federal Register notice: FDA announces a 3/7 Vaccines and Related Biological Products Advisory Committee meeting to discuss the fl...

Senate Judiciary Committee Clears 5 Drug Bills

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The Senate Judiciary Committee clears five drug-related bills that would prohibit brand manufacturers from blocking/delaying gener...

GSKs Jemperli Gets OK for Endometrial Cancer

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FDA grants full approval to GSKs Jemperli (dostarlimab-gxly) for certain adult patients with mismatch repair deficient (dMMR) recu...

Tahsildar Debarred for 2 Years Over Canadian Drugs

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Federal Register notice: FDA issues an order debarring Hassan Tahsildar for two years from providing services to a person that has...

CBER in a Transition Year: Marks

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CBER director Peter Marks says the Center is recruiting 125 new staff to work on cell and gene therapies during a transitional 202...

EUA for BD Combination Covid-Flu-RSV Test

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FDA grants an emergency use authorization for a BD molecular test that differentiates between Covid-19, the flu, and RSV.

FDA Unsure of Unprecedented Jemperli Trial Plans

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FDA medical reviewers raise concerns about GlaxoSmithKlines proposed trials of Jemperli to support a future BLA accelerated approv...

Industry VMSR Improvement Suggestions

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Two medical device associations suggest ways to improve an FDA draft guidance on the Voluntary Malfunction Summary Reporting progr...

CDER Researches Convolutional Neural Networks

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CDER describes a research study using flow microscopy and convolutional neural networks to monitor changes in product quality attr...

DiA Imagings AI Imaging Software Cleared

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FDA clears a DiA Imaging Analysis 510(k) for its LVivo IQS, a new artificial intelligence-based vendor-neutral software intended t...