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Kesimpta and Vazkepa among latest CHMP recommendations pharmatimes
February 01, 2021
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended 13 new medicines for approval in its latest meeting.
AstraZeneca COVID-19 Vaccine Recommended for use in the EU americanpharmaceuticalreview
February 01, 2021
AstraZeneca’s COVID-19 vaccine has been recommended for conditional marketing authorization (CMA) in the European Union (EU) for active immunization to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older.
European CHMP Adopts Positive Opinion for HEPLISAV-B americanpharmaceuticalreview
January 05, 2021
Dynavax Technologies announced the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on the company's Marketing Authorization Application, recommending the granting of marketing ...
CHMP Recommends Approvals of RINVOQ for the Active Psoriatic Arthritis, Ankylosing Spondylitis americanpharmaceuticalreview
December 31, 2020
AbbVie announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the approval of RINVOQ™ (upadacitinib, 15 mg), an oral, once daily selective and reversible JAK inhibitor, for the expanded ...
Pfizer, BioNTech Receive CHMP Positive Opinion for COVID-19 Vaccine americanpharmaceuticalreview
December 23, 2020
Pfizer and BioNTech announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion to recommend the conditional marketing authorization (CMA) of the Pfizer-BioNTech COVID-19 vaccine ...
European Commission to purchase additional 80 mn doses of Moderna’s COVID-19 vaccine expresspharma
December 21, 2020
Moderna announced that the European Commission has exercised its option to purchase an additional 80 million doses of mRNA-1273, Moderna’s COVID-19 vaccine candidate, bringing its confirmed order commitment to 160 million doses.
Update on assessment of the BioNTech and Pfizer BNT162b2 vaccine marketing authorisation application worldpharmanews
December 17, 2020
EMA's human medicines committee (CHMP) and its experts have been working intensively over the past weeks to evaluate data submitted by BioNTech and Pfizer in the context of the conditional marketing authorisation (CMA) application for BNT162b2 ...
European CHMP adopts positive opinion for Dynavax’s HEPLISAV-B vaccine for Hepatitis B pharmaceutical-business-review
December 15, 2020
Dynavax Technologies announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on the company's Marketing Authorization Application, recommending the granting of marketing ...
Bumper December meeting sees CHMP recommend 15 new medicines pharmatimes
December 15, 2020
The European Medicines Agency’s (EMA) committee for Medicinal Products for Human Use (CHMP) recommended 15 new medicines for approval in its final meeting of the year.
Biocon Biologics, Mylan get CHMP recommendation for approval of biosimilar insulin Aspart expresspharma
December 14, 2020
Biocon Biologics (a subsidiary of Biocon), and Mylan (a subsidiary of Viatris) have received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommending approval of the market authorisation ..

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