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Results For "BLA"

301 News Found

Imfinzi plus chemotherapy approved in China as for metastatic biliary tract cancer
Drug Approval | November 16, 2023

Imfinzi plus chemotherapy approved in China as for metastatic biliary tract cancer

Approval based on results from TOPAZ-1 global Phase III trial and a Chinese patient


USFDA accepts for review AstraZeneca’s supplemental biologics license application for self-administration of FluMist Quadrivalent
Drug Approval | October 26, 2023

USFDA accepts for review AstraZeneca’s supplemental biologics license application for self-administration of FluMist Quadrivalent

The sBLA is supported by a usability study which confirmed that individuals over 18 years of age could self-administer


Daiichi Sankyo, Merck collaborate to develop and commercialize three Daiichi Sankyo DXd ADCs
News | October 20, 2023

Daiichi Sankyo, Merck collaborate to develop and commercialize three Daiichi Sankyo DXd ADCs

Merck to pay Daiichi Sankyo a $4 billion upfront payment in addition to $1.5 billion in continuation payments over the next 24 months


Evonik and Shandong Vland Biotech form JV in China with focus on gut health products for animals
News | October 14, 2023

Evonik and Shandong Vland Biotech form JV in China with focus on gut health products for animals

Evonik China and Shandong Vland Biotech agreed to build a joint venture to expand their presence in gut health solutions products for farm animals globally


Biocon Biologics gets complete response letter from USFDA for Biosimilar Insulin Aspart
Drug Approval | October 09, 2023

Biocon Biologics gets complete response letter from USFDA for Biosimilar Insulin Aspart

The company had submitted a comprehensive Corrective and Preventive Action (CAPA) plan in September 2022


Biosergen, Alkem collaborate to develop anti-infective for severe fungal infections
News | September 26, 2023

Biosergen, Alkem collaborate to develop anti-infective for severe fungal infections

Biosergen AB is developing BSG005 for the treatment of severe and difficult-to-treat invasive fungal diseases


Asia Healthcare Holdings takes majority stake in Asian Institute of Nephrology and Urology
News | September 22, 2023

Asia Healthcare Holdings takes majority stake in Asian Institute of Nephrology and Urology

AHH will make an investment of Rs. 600 crore in the company through a mix of primary and secondary infusion


Fortis Bannerghatta conducts Karnataka's first pediatric robot-assisted surgery
Healthcare | September 20, 2023

Fortis Bannerghatta conducts Karnataka's first pediatric robot-assisted surgery

The complexity of operating on a one-year-old are many with the organs being tiny, fragile


BioNTech to lead $2 billion mRNA-based oncology therapy market despite challenges, says GlobalData
News | September 03, 2023

BioNTech to lead $2 billion mRNA-based oncology therapy market despite challenges, says GlobalData

BioNTech's diverse pipeline includes multiple drugs in Phase I, II, and III clinical trials


USFDA approves BMS’ Reblozyl as first-line treatment of anemia in adults with Myelodysplastic Syndromes
Drug Approval | September 01, 2023

USFDA approves BMS’ Reblozyl as first-line treatment of anemia in adults with Myelodysplastic Syndromes

Reblozyl is the first and only therapy to demonstrate superiority compared to an erythropoiesis stimulating agent (ESA) in MDS-related anemia