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182 News Found

Novavax files emergency use listing with WHO for Covid-19 vaccine
Biotech | November 05, 2021

Novavax files emergency use listing with WHO for Covid-19 vaccine

All modules required for regulatory review of Novavax vaccine, including CMC data, are now complete for WHO


Lancet endorses Sputnik Light for safety and immune response
News | November 03, 2021

Lancet endorses Sputnik Light for safety and immune response

Sputnik Light has been authorised in more than 15 countries with the registration process ongoing in a further 30 countries


Sun Pharma's Winlevi available in the US
Drug Approval | November 01, 2021

Sun Pharma's Winlevi available in the US

It is the first U.S. FDA approved novel topical mechanism for acne in nearly 40 years


Boehringer Ingelheim announces EMA marketing authorisation for spesolimab
Drug Approval | October 29, 2021

Boehringer Ingelheim announces EMA marketing authorisation for spesolimab

Generalized pustular psoriasis is characterized by episodes of widespread eruptions of painful, sterile pustules


Ocugen submits IND application with U.S. FDA for Covaxin phase 3 trial
Biotech | October 28, 2021

Ocugen submits IND application with U.S. FDA for Covaxin phase 3 trial

The Phase 3 study is designed to bridge data collected from the vaccine efficacy trial conducted in India to the U.S. population


Novavax files for approval of its Covid-19 vaccine in the UK
Biotech | October 27, 2021

Novavax files for approval of its Covid-19 vaccine in the UK

Filing marks first protein-based vaccine submitted to MHRA for authorization


Imfinzi plus tremelimumab significantly improved overall survival in liver cancer
Biotech | October 18, 2021

Imfinzi plus tremelimumab significantly improved overall survival in liver cancer

The trial met the primary endpoint of overall survival with a single priming dose of tremelimumab plus Imfinzi every four weeks vs. sorafenib


Sanofi says positive results from flu vaccine with mRNA booster study
Biotech | October 08, 2021

Sanofi says positive results from flu vaccine with mRNA booster study

The first study to investigate the safety and immunogenicity of both vaccines when co-administered compared to each vaccine administered separately in adults aged 65 years and older


Positive results from Lynparza with abiraterone delays Metastatic prostrate cancer
Drug Approval | September 28, 2021

Positive results from Lynparza with abiraterone delays Metastatic prostrate cancer

Prostate cancer is the second-most common cancer in men and despite an increase in the number of available treatments for men with mCRPC, five-year survival remains low


Pfizer and BioNTech receive U.S. FDA EUA for Covid-19 booster
Drug Approval | September 23, 2021

Pfizer and BioNTech receive U.S. FDA EUA for Covid-19 booster

Emergency Use Authorisation (EUA) is granted for individuals 65 years of age and older, and individuals ages 18 through 64 within certain high-risk groups