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Results For "BLA"

276 News Found

Protein found in Zebrafish can regenerate aged discs in human vertebrae
News | January 09, 2023

Protein found in Zebrafish can regenerate aged discs in human vertebrae

A study by Agharkar Research Institute (ARI), Pune, has discovered that a protein secreted from intervertebral disc cells induces disc regeneration in aged degenerated discs


Alembic receives USFDA final approval for Fesoterodine Fumarate Extended-Release Tablets
Drug Approval | January 07, 2023

Alembic receives USFDA final approval for Fesoterodine Fumarate Extended-Release Tablets

Fesoterodine Fumarate Extended-Release Tablets, 4 mg and 8 mg, have an estimated market size of US$ 177 million for twelve months ending Sep 2022


Chindex Medical acquires 10 ViewRay MRIdian Systems for advanced cancer treatment
News | January 06, 2023

Chindex Medical acquires 10 ViewRay MRIdian Systems for advanced cancer treatment

Purchase agreement with ViewRay will make state-of-the art precision radiation therapy available in China


USFDA accepts for review the biologics license application for Pfizer’s Investigational MenABCWY in adolescents
Drug Approval | December 31, 2022

USFDA accepts for review the biologics license application for Pfizer’s Investigational MenABCWY in adolescents

If approved, the vaccine could help simplify the meningococcal vaccination schedule and provide the broadest serogroup coverage of any meningococcal vaccine


Eye-Q inaugurates its new facility in Yamunanagar
Healthcare | December 30, 2022

Eye-Q inaugurates its new facility in Yamunanagar

The new facility will be able to handle four times as many patients as the previous facility.


US Federal Court dismisses cancer linkage associated with Zantac
News | December 13, 2022

US Federal Court dismisses cancer linkage associated with Zantac

The current ruling will assure the safety of the use of Ranitidine for Indian patients


Valneva and Pfizer report antibody persistence data for lyme disease vaccine candidate
News | December 05, 2022

Valneva and Pfizer report antibody persistence data for lyme disease vaccine candidate

Antibody levels remained above baseline six months after completion of a three-dose (Month 0-2-6) or a two-dose (Month 0-6) vaccination schedule


Evive enters license agreement with Acrotech Biopharma to commercialize Ryzneuta in US
News | November 24, 2022

Evive enters license agreement with Acrotech Biopharma to commercialize Ryzneuta in US

Ryzneuta is a novel dimeric G- CSF long-acting fusion protein without pegylation. The Biologics License Application (BLA) of Ryzneuta is currently under late-stage review by the US FDA for Chemotherapy-Induced Neutropenia (CIN)


Merck to acquire Imago BioSciences for $1.35 bn
News | November 22, 2022

Merck to acquire Imago BioSciences for $1.35 bn

Acquisition expands Merck’s growing hematology portfolio


GSK’s respiratory syncytial virus older adult vaccine candidate granted Priority Review by US FDA
Drug Approval | November 03, 2022

GSK’s respiratory syncytial virus older adult vaccine candidate granted Priority Review by US FDA

This is the third major regulatory milestone for the vaccine candidate following acceptance of regulatory submissions in Europe and Japan