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Industry Fights FDA on Drug Shortage Fixes: Califf

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FDA commissioner Robert Califf tells a podcast that drug manufacturers have fought FDA efforts to encourage companies to produce m...

FDA Reviewers Again Nix Intarcia Diabetes Product

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FDA medical reviewers tell the Endocrinologic and Metabolic Drugs Advisory Committee that they believe the Intarcia NDA for its IT...

Drug Preemption Defense Demanding, Attainable: Attorneys

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Two attorneys say their review of drug preemption cases shows that the defense is demanding but can be attained.

Disc Medicine Gets Fast Track for MWTX-003

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FDA grants Disc Medicine a fast-track designation for MWTX-003 and its use for treating patients with polycythemia vera.

Relmada Depression Trial Shows Promise

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Relmada Therapeutics says a Phase 3 trial in Major Depressive Disorder shows that patients treated daily with REL-1017 for up to o...

Taysha Discontinues Gene Therapy Program

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Taysha Gene Therapies says it is discontinuing the development of its gene therapy TSHA-120 program as a treatment for giant axona...

UCB Faces Another Review Delay on Bimekizumab

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UCB says its BLA for plaque psoriasis drug bimekizumab is facing another FDA review extension.

Menopauses Impact on Clinical Pharmacology Workshop

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Federal Register notice: FDAs Office of Womens Health and Office of Clinical Pharmacology announces a 10/11 public workshop: Menop...

FDA Recalls Saline Solution

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Medline Industries recalls its Hudson RCI Addipak unit dose vial, 0.9% full normal saline solution (Lot 3B085) due to sterility co...

Gene Therapy Stakeholder Info Request

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Federal Register notice: CBER requests information from stakeholders about critical scientific challenges and opportunities to adv...