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Cyltezo Exclusivity End Dates Recommended

[ Price : $8.95]

The CDER Office of Therapeutic Biologics and Biosimilars recommends expiration dates for first interchangeable exclusivity for Boe...

Lilly Obesity Drug Gains FDA Approval

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FDA approves an Eli Lilly NDA for Zepbound (tirzepatide) subcutaneous injection for chronic weight management in obese adults who ...

Support for Convalescent Plasma Registries

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CBER director Peter Marks and three medical center researchers editorialize on the value of registries to promote convalescent pla...

Organon Backs FDA Biosim Label Change

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Organon says it agrees with an FDA policy change to have a biosimilar statement accompany both biosimilars and interchangeables.

Democrats Introduce Anti Pay-for-Delay Bill

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Reps. Marie Gluesenkamp Perez (D-WA), Sean Casten (D-IL), and Gerry Connolly (D-VA) introduce a bill to ban brand companies from e...

Guide on Real-Time Oncology Reviews

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Federal Register notice: FDA makes available a guidance entitled Real-Time Oncology Review (RTOR).

FDA Approves Recor Paradise System

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FDA approves a PMA for the Recor Medical Paradise renal denervation system to treat hypertension.

CareFusion Recalls Alaris Pump Module

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Becton Dickinsons CareFusion unit recalls its Alaris Patient Controlled Analgesia infusion pump module 8120 because the compatible...

Dont Approve Amryts Filsuvez NDA: Petition

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A Lassman Law petition filed for an unidentified client asks FDA not to approve an Amryt NDA for Filsuvez to treat cutaneous manif...

Compliance Delay on Cosmetic Registration

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Federal Register notice: FDA makes available a guidance entitled Compliance Policy for Cosmetic Product Facility Registration and ...