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Results For "BLA"

301 News Found

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


USFDA Issues a CRL for the Biologics License Application for Insulin Aspart
Drug Approval | October 27, 2022

USFDA Issues a CRL for the Biologics License Application for Insulin Aspart

The CRL did not identify any outstanding scientific issues with the product.


Health Minister Mandaviya inaugurates CGHS Wellness Centres
Policy | October 20, 2022

Health Minister Mandaviya inaugurates CGHS Wellness Centres

CGHS would give robust coverage to pensioners and with new innovations and practices


Elekta and HCG launch collaborative clinical educational facility in Mumbai
News | October 15, 2022

Elekta and HCG launch collaborative clinical educational facility in Mumbai

The training center will focus on providing radiation oncologists, radiotherapy technologists, and medical physicists with the necessary skills


M. Holland join hands with LyondellBasell to distribute purell medical grade resins
Supply Chain | October 13, 2022

M. Holland join hands with LyondellBasell to distribute purell medical grade resins

New material distribution will serve medical device and pharmaceutical packaging manufacturers.


Zydus receives approval from USFDA for Mirabegron Extended-Release Tablets
Drug Approval | October 04, 2022

Zydus receives approval from USFDA for Mirabegron Extended-Release Tablets

Mirabegron is indicated for the treatment of overactive bladder (OAB) with symptoms of urinary incontinence, urgency, and frequency