Regulatory

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Image credit: peterschreiber.media | stock.adobe.com. Motiv COPD - Lunge und Bronchien
FDA Grants Priority Review to Dupixent for Uncontrolled Chronic Obstructive Pulmonary Disease

February 23rd 2024

The FDA has assigned a supplemental Biologics License Application submitted by Regeneron and Sanofi for Dupixent in the treatment of COPD with type 2 inflammation with a PDUFA date of June 27, 2024.

How AI is Changing the Drug Development Journey
How AI is Changing the Drug Development Journey

February 22nd 2024

Image credit: ibreakstock | stock.adobe.com. Multiple myeloma (cancer type) diagnosis medical concept on tablet screen with stethoscope
Regeneron's Linvoseltamab Granted FDA Priority Review for Relapsed/Refractory Multiple Myeloma

February 21st 2024

FDA Grants Priority Review to Merck’s Keytruda Combo for Endometrial Carcinoma
FDA Grants Priority Review to Merck’s Keytruda Combo for Endometrial Carcinoma

February 21st 2024

Image credit: Saiful52 | stock.adobe.com. Microscopic view of bone marrow slide feature are suggestive Multiple myeloma, also known as myeloma, is a type of bone marrow cancer.
FDA Approves New Biweekly Dosing of Johnson & Johnson’s Tecvayli for Relapsed/Refractory Multiple Myeloma

February 21st 2024

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