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FDA Official Pushes Back in UniQure Dispute

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A senior FDA official sharply criticizes UniQures investigational gene therapy for Huntington's disease, calling it a failed produ...

FDA Approves Teclistamab Combination for Multiple Myeloma

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FDA approves Janssen Biotechs Tecvayli (teclistamab) in combination with Darzalex Faspro (daratumumab hyaluronidase-fihj) for cert...

ExThera Regulatory Chief Charged With Concealing Adverse Events

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The U.S. Department of Justice charges the former chief regulatory officer at ExThera Medical Corp. with concealing serious advers...

Breakthrough Status for Hemabs Bleeding Disorder Therapy

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FDA grants Hemab Therapeutics a breakthrough therapy designation for sutacimig, an experimental therapy being developed to prevent...

Petition Asks FDA to Investigate Mayo Robotic Mastectomy

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Harmed Americans for Reform in Medical Device Safety petitions FDA to investigate the Mayo Clinics use of a robotic mastectomy dev...

Rep. Auchincloss Criticizes Commissioners Priority Voucher Program

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Rep. Jake Auchincloss (D-MA) criticizes FDAs new voucher program that offers select drugmakers sharply shortened review timelines,...

Hoeg Recruits Petitioner Seeking New SSRI Warnings

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Acting CDER director Tracy Beth Hoeg looks to hire the petitioner behind a request the Center is considering to add new Warnings t...

FDA Overhauls National Drug Codes

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FDA finalizes a sweeping overhaul of the National Drug Code system, adopting a standardized 12-digit format for the identifier use...

Partial Hold on Myotonic Dystrophy Type 1 Therapy

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FDA places a partial clinical hold on a mid-stage U.S. trial of PepGen Inc.s experimental therapy for myotonic dystrophy Type 1.

FDA Posts Fujian Genohope FDA-483

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FDA posts the form FDA-483 with six observations from a 2023 inspection at the Fujian Genohope Biotech sterile drug manufacturing ...