Imfinzi received an expanded indication for lung cancer from FDA in August 2024, and Tagrisso had been approved to treat lung cancer in China in June 2024.

FDA Warns Sanofi About API CGMP Deviations, Issues Clinical Hold on Atara Immunotherapies

By Patrick Lavery

January 23rd 2025

The agency’s newly issued letter to Sanofi amends one sent in December 2024, and stems from inspections at its Massachusetts drug manufacturing facility in June and July 2024.

TOP NEWS on grunge world map | Image Credit: © Sean K - © Sean K - stock.adobe.com

Cavazzoni Retires as CDER Director

By Susan Haigney

January 10th 2025

Patrizia Cavazzoni, director of FDA’s Center for Drug Evaluation and Research, has announced her retirement from the agency.

Science laboratory test tubes, laboratory equipment | Image Credit: © BillionPhotos.com - © BillionPhotos.com - stock.adobe.com

J&J Gets FDA Fast Track Designation for Alzheimer’s mAb, Posdinemab

By Feliza Mirasol

January 9th 2025

Posdinemab is the second tau-directed investigational therapy by J&J that has received fast track designation from FDA this year for Alzheimer’s disease.

FDA Publishes Two Guidance Documents, One in Final Version

By Patrick Lavery

January 7th 2025

The final guidance is a revision of a policy that has existed in some form since at least 2009, while a separate, draft guidance will accept public comment for consideration for its final version through April 8.

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