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Results For "clinical-data"

241 News Found

US FDA grants Lantern Pharma additional Orphan Drug tag for LP-184
Biotech | August 31, 2021

US FDA grants Lantern Pharma additional Orphan Drug tag for LP-184

The drug is also intended for the treatment of glioblastoma multiforme


Pfizer and BioNTech initiate rolling submission for Comirnaty booster dose
Drug Approval | August 26, 2021

Pfizer and BioNTech initiate rolling submission for Comirnaty booster dose

The submission to the US FDA has been initiated and they intend to file these data with the European Medicines Agency and other regulatory bodies in the coming weeks


DBT-BIRAC supported India’s first m-RNA vaccine gets nod for Phase II/III trial
Biotech | August 24, 2021

DBT-BIRAC supported India’s first m-RNA vaccine gets nod for Phase II/III trial

CDSCO gives the green signal as HGCO19 was safe, tolerable and immunogenic in the participants of the study


Second-Gen mRNA COVID-19 vaccine candidate CV2CoV show positive signs in preclinical study
Biotech | August 19, 2021

Second-Gen mRNA COVID-19 vaccine candidate CV2CoV show positive signs in preclinical study

The preclinical study provides evidence for strongly improved immune responses with second-generation mRNA backbone jointly developed by CureVac and GSK compared to CureVac’s first-generation mRNA backbone


FDA grants breakthrough device designation to Impella ECP, the world’s smallest heart pump
Drug Approval | August 19, 2021

FDA grants breakthrough device designation to Impella ECP, the world’s smallest heart pump

It measures 9 French (3 millimetres) in diameter upon insertion and removal from the body. While in the heart, it expands to support the heart’s pumping function, providing flow greater than 3.5 L/min


Novartis secures new approval in China for Cosentyx in pediatric psoriasis
Drug Approval | August 18, 2021

Novartis secures new approval in China for Cosentyx in pediatric psoriasis

Cosentyx is a proven treatment, supported by long-term five-year sustained efficacy and safety data across several inflammatory conditions and with more than 500,000 patients treated worldwide since launch


Penpulimab Monoclonal Antibody (PD-1) Obtains Marketing Approval in China
Biotech | August 11, 2021

Penpulimab Monoclonal Antibody (PD-1) Obtains Marketing Approval in China

The approval is based on a multi-centre, single-arm, open-label pivotal clinical trial


India’s gets its first bio-bank for heart failure research
Drug Approval | August 06, 2021

India’s gets its first bio-bank for heart failure research

Centre at Sree Chitra Tirunal Institute for Medical Sciences and Technology


Novavax signs agreement with European Commission for COVID19 vaccine
Biotech | August 05, 2021

Novavax signs agreement with European Commission for COVID19 vaccine

Deal for 100 million doses with additional 100 million through 2023


Johnson & Johnson single-shot COVID-19 vaccine granted emergency use listing by WHO
News | March 15, 2021

Johnson & Johnson single-shot COVID-19 vaccine granted emergency use listing by WHO

The vaccine was 85 percent effective in preventing severe disease across all regions.