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Results For "BLA"

352 News Found

BrainSpec receives FDA clearance to begin using AI-backed solution for non-invasive brain chemistry measurement
Digitisation | November 28, 2023

BrainSpec receives FDA clearance to begin using AI-backed solution for non-invasive brain chemistry measurement

First-ever brain chemistry database will allow clinicians to quickly infer brain biomarker data to support the diagnostic process in conditions such as Alzheimer's Disease


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