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Results For "BLA"

276 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


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


Mankind Pharma's PetStar ties up with Ranbir Kapoor and Neetu Kapoor for new campaign
News | December 06, 2023

Mankind Pharma's PetStar ties up with Ranbir Kapoor and Neetu Kapoor for new campaign

The esteemed duo perfectly embody the brand's core values of family, love, and the special bond we share with our pets


Surgeons at Aster RV Hospitals achieve milestone with removal of 345 gallstones
Healthcare | November 28, 2023

Surgeons at Aster RV Hospitals achieve milestone with removal of 345 gallstones

This surgery presented unique challenges, particularly due to the size of the gallbladder and the multitude of stones


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