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Bill Would Prevent Conflicting FDA Consultant Contracts

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A Senate bill seeks to bar conflicts of interest in consulting contracts, such as those FDA signed with McKinsey & Co. on regulato...

Staar Surgical Implantable Vision Correction Lens OKd

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FDA approves a Staar Surgical PMA for the EVO/EVO+ Visian Implantable Collamer Lens for correcting myopia and myopia with astigmat...

Drug User Fee Notice Correction

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Federal Register notice: FDA corrects an 8/16/2021 notice entitled Prescription Drug User Fee Rates for Fiscal Year 2022.

Review Extension Bristol-Myers sBLA for Reblozyl

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Reblozyl is currently approved to address transfusion-dependent anemia-associated beta thalassemia and lower-risk myelodysplastic ...

BMS Resolves Abraxane Drug Shortage

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Bristol-Myers Squibb says it has resolved manufacturing constraints that led to global supply challenges for Abraxane for injectab...

AviClear Acne Laser Treatment Cleared

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FDA clears a Cutera 510(k) for AviClear, a laser treatment for mild, moderate, and severe acne.

FDA PI3K Concerns Hits MEI Pharmas Zandelisib

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Ongoing FDA concerns about PI3K inhibitors prompts the agency to discourage MEI Pharma and Kyowa Kirin from seeking accelerated ap...

House Panel Grills FDA on Medtronic Heart Pump

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The House Oversight and Reform committee asks FDA for answers to what regulatory enforcement actions it sought against Medtronics ...

Senate Passes Marijuana/CBD Research Bill

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The Senate passes the Cannabidiol and Marijuana Research Expansion Act that is intended to ensure that research on cannabidiol and...

GSK/Vir Sotrovimab EUA Excludes New Variant Use

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FDA amends a GlaxoSmithKline and Vir Biotechnology Emergency Use Authorization for sotrovimab because the 500mg therapy is unlikel...