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Objectionable Conditions in Bioresearch Monitoring Inspection

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FDA warns Dr. Bertrand Cole in Portsmouth, NH, about failing to conduct a clinical study according to the investigational plan.

FDA Flip Flops; Agrees to Now Review Moderna Vaccine

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FDA reverses course and agrees to review Modernas seasonal influenza mRNA vaccine after previously refusing to file the BLA.

2025 Medical Device Recalls Down, Drug Recalls Up

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The Sedgwick Recall Index year-end report for 2025 finds that the number of medical device recalls dropped compared to 2024, while...

FDA Officials Discuss One Trial Standard

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An FDA perspective in the New England Journal of Medicine outlines the agencys move away from requiring two pivotal trials for dru...

Lilly Sees Positive Data in TaltzZepbound Combo

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Eli Lilly says that combining its psoriasis biologic Taltz (ixekizumab) with obesity drug Zepbound (tirzepatide) led to significan...

FDA Accepts for Review Hansa Biopharma Imlifidase BLA

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FDA accepts for review the Hansa Biopharma BLA for imlifidase to be used in kidney transplantation.

GLP-1 Crackdown, OTC Push and Faster Ph.1 Timelines: Makary

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FDA commissioner Marty Makary says the agency will step up enforcement against unlawful mass compounding of GLP-1 weight-loss drug...

More Consistent Rare Disease Flexibility Needed: Attorneys

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Three Hyman, Phelps & McNamara attorneys call on FDA to be more consistently flexible in dealing with regulatory approvals of rare...

Rare Disease Innovation Hub 2026 Strategic Agenda

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The FDA Rare Disease Innovation Hub sets eight action items for 2026.

BMS Files NDA for Multiple Myeloma

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FDA accepts for priority review a Bristol Myers Squibb NDA for iberdomide in combination with daratumumab and dexamethasone for pa...