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1381 News Found

USFDA grants ILiAD Biotechnologies Fast Track Designation for pertussis vaccine
Biotech | January 04, 2022

USFDA grants ILiAD Biotechnologies Fast Track Designation for pertussis vaccine

BPZE1 is the most advanced next-generation pertussis vaccine currently in clinical development


Combination of Covishield-Covaxin more effective: AIG hospital study
News | January 04, 2022

Combination of Covishield-Covaxin more effective: AIG hospital study

The first pilot study from India analyzing Covaxin-Covishield mixed doses


Novavax submits data to U.S. FDA for Covid-19 EUA
Biotech | January 03, 2022

Novavax submits data to U.S. FDA for Covid-19 EUA

Emergency Use Authorisation application request to be submitted following one month required by FDA EUA guidance


Celltrion announces positive results for its cocktail Covid-19 therapy candidates
Biotech | January 03, 2022

Celltrion announces positive results for its cocktail Covid-19 therapy candidates

Celltrion plans to provide dual treatment options for COVID-19; Regkirona for hospitalised patients and a nebulised cocktail therapy (CT-P63 in combination with Regkirona) for at- home settings


India’s 1st indigenously developed protein sub-unit Covid-19 vaccine Corbevax gets nod
Drug Approval | December 28, 2021

India’s 1st indigenously developed protein sub-unit Covid-19 vaccine Corbevax gets nod

It plans to deliver over 300 million doses to the Indian government


Roche gets U.S. FDA nod for at-home Covid-19 self-testing solution
Medical Device | December 27, 2021

Roche gets U.S. FDA nod for at-home Covid-19 self-testing solution

The Covid-19 At-Home Test uses a simple nasal swab sample to enable individuals to self-test at home and receive accurate, reliable and quick results in as few as 20 minutes for SARS-CoV-2 and all known variants of concern, including Omicron


Lecanemab granted Fast Track designation by the U.S. FDA
Biotech | December 24, 2021

Lecanemab granted Fast Track designation by the U.S. FDA

Alzheimer's disease is a serious, progressive and devastating disease with few treatment options


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


Moderna says Covid-19 booster dose works against Omicron in lab study
News | December 20, 2021

Moderna says Covid-19 booster dose works against Omicron in lab study

Authorized booster increases Omicron neutralizing antibody levels approximately 37-fold


Astra Zeneca’s antibody combination to prevent Covid-19 neutralises Omicron variant
News | December 17, 2021

Astra Zeneca’s antibody combination to prevent Covid-19 neutralises Omicron variant

The study was performed independently by investigators at the US Food and Drug Administration (FDA), Center for Biologics Evaluation and Research