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2731 News Found

Sandoz submits Biologics License Application for proposed biosimilar trastuzumab to US FDA
Biotech | December 21, 2021

Sandoz submits Biologics License Application for proposed biosimilar trastuzumab to US FDA

Trastuzumab is monoclonal antibody used to treat human epidermal growth factor receptor 2 positive (HER2+) breast cancer and metastatic gastric cancers


CDSCO increases shelf life of Covaxin
Drug Approval | December 21, 2021

CDSCO increases shelf life of Covaxin

The approval of shelf life extension is based on the availability of additional stability data, which was submitted to the CDSCO


WHO grants EUL for Covovax
Drug Approval | December 20, 2021

WHO grants EUL for Covovax

First Emergency Use Listing granted by WHO for a protein-based Covid-19 vaccine


Gamaleya claims the Sputnik V perfect booster against Omicron
News | December 20, 2021

Gamaleya claims the Sputnik V perfect booster against Omicron

Sputnik Light as a booster significantly increases virus-neutralizing activity against Omicron based on sera 2-3 months after revaccination and is a universal booster to other vaccines inducing stronger antibody and T-cell response


Sun gets US FDA approval for generic amphotericin B injection
Drug Approval | December 16, 2021

Sun gets US FDA approval for generic amphotericin B injection

It is the first approved generic and is eligible for 180 days of Competitive Generic Therapy exclusivity


Syngene extends contract with Amgen till 2026
News | December 16, 2021

Syngene extends contract with Amgen till 2026

Syngene will also build and operate a new dedicated drug development laboratory to accelerate the advancement of Amgen R&D projects


Lo.Li Pharma International seeks partners for Deplesin therapy
Biotech | December 15, 2021

Lo.Li Pharma International seeks partners for Deplesin therapy

Deplesin is an add-on therapy to gold standard agents like lithium, valproic acid, and carbamazepine, supporting patients in ways that prescription medications often cannot


CellCarta acquires Biogazelle to strengthen its genomic capabilities
Medical Device | December 15, 2021

CellCarta acquires Biogazelle to strengthen its genomic capabilities

While continuing to offer its current breadth of genomic services, Biogazelle will become CellCarta's Center of Excellence for the development of complex genomic biomarker assays


HealthPlix releases Prescription Summary Dashboard for doctors
Healthcare | December 15, 2021

HealthPlix releases Prescription Summary Dashboard for doctors

Doctors can now analyse their historical prescriptions within a few clicks enabling them to identify different cohorts of patients and the treatment given to them


Lupin’s Goa plant receives EIR from US FDA
News | December 14, 2021

Lupin’s Goa plant receives EIR from US FDA

FDA changes inspection classification of the facility to Voluntary Action Indicated