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Updated Accelerated Approval Guidance

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FDA publishes a draft guidance updating its accelerated approval policies and procedures based on new authority from the 2023 Cons...

Genentech sBLA for Columvi Accepted for Review

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FDA accepts for review a Genentech supplemental BLA for Columvi (glofitamab-gxbm) in combination with gemcitabine and oxaliplatin...

29 Drugs Not Withdrawn Due to Safety/Efficacy: FDA

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Federal Register notice: FDA determines that 29 drug products listed in the notice were not withdrawn from sale for reasons of saf...

FDA Approves AZs Lung Cancer Drug Imfinzi

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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...