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Lillys Bebtelovimab Not Authorized in U.S.

[ Price : $8.95]

FDA says Lillys bebtelovimab is not authorized for use in any U.S. region because it is not active against two key Omicron subvari...

Eisai/Biogen Report Promising Alzheimers Data

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Eisai and Biogen report new data from a lecanemab Alzheimers Phase 3 trial that suggest treated patients with early Alzheimers dis...

Ferrings Fecal Microbiota Product Approved for C.diff

[ Price : $8.95]

FDA approves Ferring Pharmaceuticals Rebyota (fecal microbiota) for preventing recurrence of Clostridioides difficile infection in...

Ex-BD Official Seeks DoJ Referral Against Company

[ Price : $8.95]

A former Becton Dickinson safety official petitions FDA to refer the company to the U.S. Justice Department for allegedly violatin...

Objectionable Conditions at Arbor Eyecare

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FDA warns Arbor Centers for EyeCare about objectionable conditions in its conduct of two clinical investigations.

Guide on Fecal Microbiota Enforcement Policy

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Federal Register notice: FDA makes available a final guidance entitled Enforcement Policy Regarding Investigational New Drug Requi...

CDER Hearing Delay on NDA is Unfounded: Lexicon

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Lexicon asks that its NDA for sotagliflozin be approved to treat Type 1 diabetes or that a hearing be held to resolve issues of fa...

Suggestions to Improve OTC Drug Draft Reg

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Five stakeholders recommend changes to an FDA proposed rule on nonprescription drug products with an additional condition for nonp...

Roche Withdraws Tecentriq Bladder Cancer Indication

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Roche withdraws a Tecentriq (atezolizumab) accelerated approval indication for treating certain adults with locally advanced or me...

Mylan Requests Sulfamylon Withdrawal

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Federal Register notice: FDA withdraws the approval of Mylans Sulfamylon (mafenide acetate, USP) powder for 5% topical solution af...