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2554 News Found

FDA and EMA accept Marstacimab regulatory submissions for the treatment of Hemophilia A and B
Drug Approval | December 13, 2023

FDA and EMA accept Marstacimab regulatory submissions for the treatment of Hemophilia A and B

Submissions based on positive data from the Phase 3 BASIS trial, which were presented this past weekend at the American Society of Hematology (ASH) Annual Meeting


Wockhardt announces successful completion of pivotal Phase 3 pneumonia study of its macrolide antibiotic Nafithromycin WCK 4873
News | December 12, 2023

Wockhardt announces successful completion of pivotal Phase 3 pneumonia study of its macrolide antibiotic Nafithromycin WCK 4873

The findings of Phase 3 study are in line with Phase 2 study conducted in the US and Europe


European Commission approves Pfizer’s Elrexfio for multiple myeloma
Drug Approval | December 09, 2023

European Commission approves Pfizer’s Elrexfio for multiple myeloma

Conditional marketing authorization is based on clinically meaningful response rates, duration of response, and safety from the Phase 2 MagnetisMM-3 trial


Zepbound is now available in US for adults living with obesity
News | December 09, 2023

Zepbound is now available in US for adults living with obesity

Express Scripts to add Zepbound to National Preferred Formulary


Sarclisa Phase 3 trial met primary endpoint of progression free survival with newly diagnosed multiple myeloma not eligible for transplant
News | December 08, 2023

Sarclisa Phase 3 trial met primary endpoint of progression free survival with newly diagnosed multiple myeloma not eligible for transplant

Sarclisa added to bortezomib, lenalidomide and dexamethasone (VRd) significantly reduced the risk of disease progression or death compared with VRd alone


AbelZeta Pharma, AstraZeneca to co-develop a novel GPC3 armored CAR-T therapy in China
News | December 08, 2023

AbelZeta Pharma, AstraZeneca to co-develop a novel GPC3 armored CAR-T therapy in China

C-CAR031 is based on a novel GPC3-targeting CAR-T (AZD5851) designed by AstraZeneca using their transforming growth factor-beta receptor II


Roche to acquire Carmot Therapeutics for US$ 2.7 billion
News | December 05, 2023

Roche to acquire Carmot Therapeutics for US$ 2.7 billion

Carmot Therapeutics’s R&D portfolio of clinical stage incretins has great potential to treat obesity, diabetes and potentially other diseases


USFDA inspection at Alkem Laboratories API manufacturing facility located at Mandva
News | December 02, 2023

USFDA inspection at Alkem Laboratories API manufacturing facility located at Mandva

The company has received Form 483 with three observations


New global survey finds widespread misunderstandings about shingles despite its lifetime prevalence
News | December 01, 2023

New global survey finds widespread misunderstandings about shingles despite its lifetime prevalence

A new GSK survey shows a large number of adults do not understand how shingles may be triggered


Dupixent significantly reduced COPD exacerbations in second positive Phase 3 trial
Clinical Trials | November 29, 2023

Dupixent significantly reduced COPD exacerbations in second positive Phase 3 trial

Accelerating FDA submission and confirming potential to become first approved biologic for this serious disease