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EMA begins evaluation of filgotinib for ulcerative colitis pharmatimes
November 05, 2020
Gilead and Galapagos’ application seeking approval for their oral JAK1 inhibitor filgotinib as a treatment for ulcerative colitis has been validated by the European Medicines Agency (EMA).
EMA accepts marketing application for Biogen, Eisai’s Alzheimer’s therapy pharmaceutical-technology
November 04, 2020
Biogen and Eisai have announced that the European Medicines Agency (EMA) accepted to review the marketing authorisation application (MAA) for aducanumab, an investigational antibody therapy for Alzheimer’s disease.
FDA grants priority review and EMA accepts regulatory submission for Pfizer’s abrocitinib pharmaceutical-business-review
October 30, 2020
Pfizer announced that the U.S. Food and Drug Administration (FDA) accepted for filing and granted Priority Review designation to the company’s New Drug Application (NDA) for abrocitinib (100mg and 200mg) ...
EMA recommends 10 medicines for approval in October meeting europeanpharmaceuticalreview
October 23, 2020
Ten medicines have been recommended for marketing authorisation and 10 extensions of indication have been suggested by the EMA.
Aimmune’s peanut allergy med moves toward EU approval pharmatimes
October 22, 2020
Aimmune has been granted a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for its drug Palforzia as a treatment of peanut allergic patients aged 4-17 years.
Akero Therapeutics Receives European Medicines Agency Priority Medicines (PRIME) Designation for Efruxifermin (EFX) in NASH prnewswire
October 21, 2020
Akero Therapeutics, Inc. announced that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation to efruxifermin (EFX), an investigational FGF21 analog for the treatment of NASH.
Prestige Biopharma drug gets positive EMA opinion on Orphan Designation to treat pancreatic cancer expresspharma
October 19, 2020
Prestige BioPharma announced that the European Medicines Agency (EMA) Orphan Drug Commission (COMP) has granted a positive opinion for an Orphan Drug Designation (ODD) status to its first-in-class anti-PAUF monoclonal antibody, PBP1510, for the ...
EMA confirms eligibility for submission of Moderna’s COVID-19 vaccine pharmatimes
October 16, 2020
The European Medicines Agency (EMA) has confirmed that Moderna’s COVID-19 vaccine candidate mRNA-1273 is eligible for submission under the agency’s centralised procedure.
EMA begins rolling review of BNT162b2 COVID-19 vaccine europeanpharmaceuticalreview
October 16, 2020
The rolling review of BNT162b2 will allow the committee for human medicines (CHMP) to reach a faster decision on a future marketing authorisation application.
EMA accepts filing for Biogen/Samsung Bioepis’ Lucentis biosimilar pharmatimes
October 10, 2020
The European Medicines Agency (EMA) has accepted for review the marketing authorisation for Biogen and Samsung Bioepis’ biosimilar referencing Genentech's Lucentis (ranibizumab).

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