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Results For "BLA"

264 News Found

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


Jemperli plus chemotherapy approved in the US as the first new frontline treatment option for dMMR/MSI-H primary advanced or recurrent endometrial cancer
Drug Approval | August 01, 2023

Jemperli plus chemotherapy approved in the US as the first new frontline treatment option for dMMR/MSI-H primary advanced or recurrent endometrial cancer

Jemperli is the only immuno-oncology treatment approved in the frontline setting for this patient population in combination with chemotherapy


Moderna announces regulatory submissions for its RSV vaccine
News | July 10, 2023

Moderna announces regulatory submissions for its RSV vaccine

The company has submitted marketing authorization applications for mRNA-1345 with the European Medicines Agency (EMA), Swissmedic in Switzerland, and the Therapeutic Goods Administration (TGA) in Australia


Astellas receives FDA priority review for Zolbetuximab biologics license application
Drug Approval | July 10, 2023

Astellas receives FDA priority review for Zolbetuximab biologics license application

Astellas stands on the forefront of healthcare change to turn innovative science into value for patients


BDR Pharma's Nilotinib sets a new standard in the treatment of Philadelphia Chromosome-positive leukaemia
News | July 05, 2023

BDR Pharma's Nilotinib sets a new standard in the treatment of Philadelphia Chromosome-positive leukaemia

Rare childhood cancer subtype, Ph+ ALL, is found in 3-4% of pediatric cases and 25% of adult cases


GSK receives USFDA file acceptance for Jemperli plus chemotherapy for the treatment of endometrial cancer
Drug Approval | June 12, 2023

GSK receives USFDA file acceptance for Jemperli plus chemotherapy for the treatment of endometrial cancer

Application being reviewed under the FDA Project Orbis framework, which enables concurrent reviews among US, Australia, Canada, Switzerland, Singapore and United Kingdom health authorities