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FDA Accepts Accords Herceptin Biosimilar BLA

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FDA accepts for review an Accord BioPharma BLA for HLX02, a proposed trastuzumab (Roches Herceptin) biosimilar for treating certai...

Drug Shortage Mitigation Guidance

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FDA issues a draft guidance recommending to applicants and manufacturers drug shortage information to be communicated to FDA to as...

Lab Tests Could be in Preparedness Bill

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The political newsletter Roll Call says efforts to reauthorize a pandemic preparedness bill are likely to include a debate over gr...

QuVa Pharma FDA-483

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FDA releases the form FDA-483 with three observations issued following an inspection at the Sugar Land, TX-based QuVa Pharma outso...

CDER is in Growth Mode from Hiring Spree: Cavazzoni

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CDER director Patrizia Cavazzoni tells the Alliance for a Stronger FDA that the Center is in growth mode after the user fee reauth...

FDA OKs Synapse Bio PMA for Breathing System

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FDA approves a Synapse Biomedical PMA for the NeuRx Diaphragm Pacing System for use in patients with spinal cord injuries who rely...

FDA on Pharmacodynamic Biomarker Research

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FDA outlines research into potential pharmacodynamic biomarkers for biosimilar development.

Docket Open for Opioids Home Disposal REMS

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Federal Register notice: FDA establishes a docket to obtain information and comments to help assess whether in-home disposal produ...

FDA Selecting Fall Covid Vaccine Make-up in June

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CBER director Peter Marks says Covid-19 vaccine makers will be given advice in June on the next booster vaccine composition for fa...

Phathom Plans to Resubmit NDA, and Supplemental NDA

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Phathom Pharmaceuticals says it will resubmit an NDA for vonoprazan for treating erosive esophagitis, and a post-approval suppleme...