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EMA initiates rolling review of Russia’s Sputnik V vaccine for Covid-19 pharmaceutical-technology
March 05, 2021
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has initiated a rolling review of the Russian Covid-19 vaccine, Sputnik V.
GW Receives Positive CHMP Opinion for EPIDYOLEX for TSC Seizures americanpharmaceuticalreview
March 04, 2021
GW Pharmaceuticals announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on the Company’s Type II variation application for EPIDYOLEX® (cannabidiol) as an adjunctive ...
CHMP Adopts Positive Opinion for Evrysdi for Spinal Muscular Atrophy americanpharmaceuticalreview
March 03, 2021
PTC Therapeutics announced the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Evrysdi™ (risdiplam) for the treatment of 5q spinal muscular atrophy (SMA) in patients 2 months and ...
Evrysdi leads latest CHMP recommendations pharmatimes
March 02, 2021
The European Medicines Agency’s (EMA) Committee for Medicines for Human Use (CHMP) has recommended six medicines for approval at its February meeting.
CHMP opinions: EMA refuses asthma label expansion for GSK’s COPD drug Trelegy Ellipta pharmaceutical-technology
March 02, 2021
The European Union’s healthcare regulator the European Medicines Agency (EMA) has decided against a label expansion for GlaxoSmithKline (GSK)’s drug Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) to include asthma.
EMA issues its requirements for adapting COVID-19 vaccines for viral variants europeanpharmaceuticalreview
March 01, 2021
The European Medicines Agency has set out its guidelines for vaccine manufacturers adapting their approved COVID-19 vaccines to combat viral variants.
Biocon Biologics and Viatris get CHMP Nod for Abevmy expresspharma
March 01, 2021
Biocon Biologics, a subsidiary of Biocon announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the marketing authoris ation of their biosimilar Bevacizumab ...
Ontozry Receives Positive CHMP Opinion Treatment of Uncontrolled Focal Onset Seizures americanpharmaceuticalreview
February 04, 2021
Arvelle Therapeutics announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of cenobamate for the adjunctive treatment of focal onset seizures with or without secondary ...
EMA committee recommends 13 medicines for approval in January meeting europeanpharmaceuticalreview
February 02, 2021
The committee for human medicinal products recommended AstraZeneca’s COVID-19 vaccine be granted conditional marketing authorisation alongside 12 other approvals.
Novo Nordisk’s Sogroya moves closer towards EU approval pharmatimes
February 02, 2021
Novo Nordisk’s Sogroya (somapacitan) has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use – moving closer towards approval in the EU.

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