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Results For "European-Medicines-Agency"

207 News Found

Johnson & Johnson booster dose indicate impressive results
Drug Approval | August 26, 2021

Johnson & Johnson booster dose indicate impressive results

New interim data from these studies demonstrate that a booster dose of the Johnson & Johnson Covid-19 vaccine generated a rapid and robust increase in spike-binding antibodies, nine-fold higher than 28 days after the primary single-dose vaccination.


Pfizer & BioNTech submits Phase 1 data to US FDA for booster dose Covid-19
Biotech | August 17, 2021

Pfizer & BioNTech submits Phase 1 data to US FDA for booster dose Covid-19

The data suggest that a booster dose given within 6 to 12 months after the second dose may help maintain a high level of protection against COVID-19.


Cadila Healthcare net profit at Rs 587.2 cr in Q1FY22
News | August 11, 2021

Cadila Healthcare net profit at Rs 587.2 cr in Q1FY22

The company has also applied to DCGI for Emergency Use Authorization (EUA) for ZyCoVD, the world's first Plasmid DNA Vaccine


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


EMA grants ODD to Saroglitazar Mg
News | July 21, 2021

EMA grants ODD to Saroglitazar Mg

Earlier, the USFDA has granted ‘Orphan Drug Designation’ and ‘Fast Track Designation’ to Saroglitazar Mg for PBC


Biocon and Viatris receive EC approval for Biosimilar Bevacizumab
Biotech | April 28, 2021

Biocon and Viatris receive EC approval for Biosimilar Bevacizumab

The drug is approved for the treatment in metastatic colorectal carcinoma, metastatic breast cancer and ovarian, cervical and renal cancer


Biocon Biologics and Viatris receive European Commission approval for Kixelle, Biosimilar Insulin Aspart
Biotech | February 13, 2021

Biocon Biologics and Viatris receive European Commission approval for Kixelle, Biosimilar Insulin Aspart

The centralized marketing authorization granted by the EC is valid in all EU Member