-
CHMP recommends EU approval of Actemra/RoActemra to treat patients with severe COVID-19
expresspharma
December 07, 2021
Actemra/RoActemra reduced the risk of death in patients with severe COVID-19, as evidenced by a review of four phase-III studies. The European Commission is expected to make a final decision regarding approval in the near future.
-
CHMP issue positive opinion on Comirnaty® for five to 11 year olds
EuropeanPharmaceuticalReview
December 02, 2021
Pfizer and BioNTech have announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion on the administration of the companies’ COVID-19...
-
CHMP recommends use of Pfizer-BioNTech’s Covid-19 vaccine in children
Pharmaceutical-Business-Review
November 29, 2021
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the use of Pfizer and BioNTech’s Covid-19 vaccine, Comirnaty, in children aged five to 11 years.
-
EMA recommends Pfizer-BioNTech’s Covid-19 vaccine for children
Pharmaceutical-Technology
November 29, 2021
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion on the use of Pfizer and BioNTech’s Covid-19 vaccine, Comirnaty, in children aged five to 12 years.
-
EMA CHMP recommends authorisation of Roche-Regeneron’s Covid-19 therapy
Pharmaceutical-Technology
November 15, 2021
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the EU approval of Roche and Regeneron’s Ronapreve...
-
EU backs approval of Moderna’s COVID-19 vaccine in 12-17 year-olds
pharmatimes
July 28, 2021
Moderna’s COVID-19 vaccine has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for use in adolescents aged 12 to 17 years of age.
-
EMA’s human medicine committee (CHMP) meeting highlights, July 2021
europeanpharmaceuticalreview
July 27, 2021
The Committee for Medicinal Products for Human Use (CHMP) recommended two medicines for approval and provided a negative opinion on Nouryant.
-
CHMP recommends expanded use for Alexion’s PNH therapy Ultomiris
pharmatimes
July 27, 2021
AstraZeneca’s (AZ) Ultomiris has received a positive recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) to expand its use to include children and adults with ...
-
BMS’ CAR T therapy Abecma moves closer toward EU approval
pharmatimes
June 29, 2021
Bristol Myers Squibb’s (BMS) CAR T cell therapy Abecma has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), recommending its approval for the treatment of relapsed and ...
-
CHMP recommends approval of UCB’s Bimzelx for plaque psoriasis
pharmatimes
June 29, 2021
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval for UCB’s Bimzelx as a treatment for moderate-to-severe plaque psoriasis.