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Panel to Weigh Favorable Data on Moderna's mRNA Flu Vaccine

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A 6/18 advisory committee meeting is set to review Moderna's investigational mRNA influenza vaccine as the agency posts a briefing...

FDA Delays Isotretinoin REMS Modifications

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FDA says there is an implementation delay for isotretinoin iPLEDGE Risk Evaluation and Mitigation Strategy modif...

Zoll Medical QSR, MDR Violations

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FDA warns Chelmsford, ME-based Zoll Medical about Quality System and Medical Device Reporting violations in its manufacturing of s...

CGMP Violations Found in Sante Manufacturing Records

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FDA warns Canadas Sante Manufacturing about CGMP issues found in an agency review of requested records detailing the firms manufac...

FDA Fails at Providing Risk Management Advice: Post

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North Dakota State University economist Raymond March faults the way in which FDA provides risk management guidance to regulated c...

Restrict Some Lung Cancer Drugs: Petition

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A cancer center precision medicine expert calls on FDA to require labeling changes for some non-small cell lung cancer immune chec...

Draeger Anesthesia Workstation Correction Expanded

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Draeger expands a 10/2024 device correction (Class 1 recall) to include additional Atlan A350 and A350XL anesthesia workstations u...

FDA Warns Pharmathen Over Sterility, Data Integrity Concerns

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FDA sends a Warning Letter to Greek contract manufacturer Pharmathen International citing significant GMP violations at its steril...

Jaypirca Combination Cuts Progression Risk by 45% in CLL Trial: Lilly

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Eli Lilly reports positive Phase 3 results for its BTK inhibitor Jaypirca (pirtobrutinib) in combination with venetoclax and ritux...

Plausible Mechanism Faces Challenges: Commentary

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Significant operational hurdles remain before FDA's Plausible Mechanism Framework can be broadly implemented, according to a comme...