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Human Drugs

Merck in Keytruda Patent Dispute with Johns Hopkins

Merck sues Johns Hopkins University in Maryland federal court over patents Hopkins obtained following a research collaboration with Merck using Keytru...

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Human Drugs

Lillys Bebtelovimab Not Authorized in U.S.

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

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Human Drugs

Eisai/Biogen Report Promising Alzheimers Data

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

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Human Drugs

Ferrings Fecal Microbiota Product Approved for C.diff

FDA approves Ferring Pharmaceuticals Rebyota (fecal microbiota) for preventing recurrence of Clostridioides difficile infection in individuals 18 year...

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Medical Devices

Ex-BD Official Seeks DoJ Referral Against Company

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

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Human Drugs

Objectionable Conditions at Arbor Eyecare

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

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Federal Register

Guide on Fecal Microbiota Enforcement Policy

Federal Register notice: FDA makes available a final guidance entitled Enforcement Policy Regarding Investigational New Drug Requirements for Use of F...

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Human Drugs

CDER Hearing Delay on NDA is Unfounded: Lexicon

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

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Human Drugs

Suggestions to Improve OTC Drug Draft Reg

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

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Human Drugs

Roche Withdraws Tecentriq Bladder Cancer Indication

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