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FDA Approves AZs Lung Cancer Drug Imfinzi

[ Price : $8.95]

FDA approves AstraZenecas Imfinzi to treat some adults with limited-stage small cell lung cancer.

Rayner Wants Generic Omidria Restrictions

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Rayner Surgical petitions FDA to restrict approval of any ANDA citing Omidria as the reference-listed drug.

Protara Reports Positive Data on Bladder Cancer Drug

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Protara Therapeutics reports encouraging data from a Phase 2 trial of its cell-based TARA-002 in certain high-risk non-muscle inva...

EpicentRx Gets Fast Track for Sarcoma Therapy

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FDA grants EpicentRx a fast-track designation for its AdAPT-001 and its combination use with checkpoint inhibitors in treating rec...

Breakthrough Status for Ventricular Tachycardia Ablator

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FDA grants Field Medical a breakthrough device designation for its FieldForce Ablation System for treating sustained monomorphic s...

Shortage of Empty IV Containers

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FDA adds empty IV containers to the medical device shortages list and says the shortage is likely to last until 3/2025.

FDA Clears Zimmer Persona Femur

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FDA clears the Zimmer Biomet Persona SoluTion total knee replacement component for patients with sensitivities to bone cement or m...

Merus Bizengri Wins Accelerated Approval

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FDA grants Merus accelerated approval for Bizengri (zenocutuzumab-zbco) for certain adults with advanced, unresectable, or metasta...

Drug-Induced Liver Injury Indicator Seen: FDA

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FDAs National Center for Toxicological Research finds a new predictor for drug-induced liver injury.

Require Prednisolone Solution Studies: DifGen

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DifGen asks FDA to require stability studies under refrigerated conditions for all ANDAs for prednisolone ophthalmic solution 1%.