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FDA Accepts Outlook Therapeutics' Resubmitted BLA for Lytenava

[ Price : $8.95]

FDA accepts for review a BLA resubmission from Outlook Therapeutics seeking approval of ONS-5010/Lytenava (bevacizumab-vikg) for t...

Leadership Changes Affect FDA Priorities: Mintz Post

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Two Mintz attorneys examine what has happened to some of former FDA commissioner Marty Makarys initiatives following his resignati...

Petition Urges FDA to Restrict Antibiotic Use in Animals

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A coalition of 65 health, environmental, consumer, farming, and animal welfare organizations petition FDA to withdraw approvals fo...

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...