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Regeneron Plans Garetosmab FDA Submission

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Regeneron says it will submit an application to FDA by the end of 2025 seeking approval for its garetosmab to treat adults with fi...

Leverage FDA Alternative Tools Flexibility: Attorneys

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Three Sidley attorneys suggest ways drug companies can take advantage of the flexibility in FDAs guidance on using alternative too...

Alert on Abbotts TactiFlex Ablation Catheter

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FDA issues an alert after becoming aware that Abbott issued a letter to customers recommending updated instructions when removing ...

6 Observations in Fagron Outsourcing Inspection

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FDA releases the form FDA-483 with six observations from an inspection at Wichita, KS-based Fagron Compounding Services.

FDA Approves 2 Biocon Denosumab Biosimilars

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FDA approves Biocon Biologics biosimilars for Amgens Prolia and Xgeva.

Safety Labeling Changes Guidance

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FDA issues a draft guidance revising and updating a 2013 guidance on safety labeling changes when new safety information becomes a...

Committee Advances Pediatric Voucher Reauthorization

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The House Energy and Commerce Committee unanimously approves legislation to reauthorize FDAs Rare Pediatric Disease Priority Revie...

Developing Disseminated Coccidiodomycosis Drugs

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FDA publishes a draft guidance to help sponsors with clinical trials for drugs to treat disseminated coccidiomycosis.

Lillys Oral Diabetes Drug Outperforms Rival in Head-to-Head Trial

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Eli Lilly reports that it oral diabetes drug orforglipron achieved stronger blood sugar and weight loss results than Novo Nordisks...

Ex-CDC Chief Says FDA Facing Similar Political Pressure

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Former CDC director Susan Monarez says FDA and other health agencies are facing similar political pressure that she experienced to...