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CHMP

Showing 15 posts of 103 posts found.

CHMP recommends Novo Nordisk’s Awiqli for diabetes treatment

March 22, 2024
Medical Communications CHMP, Diabetes, Novo Nordisk, diabetes

Novo Nordisk has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended …

News
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EMA validates two applications for datopotamab deruxtecan for cancer treatments

March 4, 2024
Medical Communications CHMP, Daiichi Sankyo, EMA, Oncology, datopotamab deruxtecan

AstraZeneca has announced that the European Medicines Agency (EMA) has validated to marketing authorisation applications (MAAs) for AstraZeneca and Daiichi …

News

AstraZeneca’s Voydeya recommended for approval in EU by CHMP

February 29, 2024
Medical Communications AstraZeneca, CHMP, EMA, Haematology, Voydeya

AstraZeneca has announced that Voydeya (danicopan) has been recommended for marketing authorisation in the European Union (EU) by the Committee …

News
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GSK gains positive CHMP opinion for momelotinib for myelofibrosis treatment

November 13, 2023
Medical Communications CHMP, GSK, Haematology, anaemia, momelotinib, myelofibrosis

GSK has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has …

News

Iveric Bio’s marketing authorisation application for avacincaptad pegol accepted by EMA

August 18, 2023
Medical Communications CHMP, EMA, Iveric Bio, MAA, Opthalmology

Astellas Pharma has announced that the European Medicines Agency (EMA) has accepted the marketing authorisation application (MAA) for avacincaptad pegol …

News
Vaccine image

ViiV Healthcare gains positive CHMP opinion for cabotegravir for HIV prevention

July 24, 2023
Medical Communications CHMP, EMA, HIV, HIV/AIDS, ViiV Healthcare, cabotegravir

GSK has announced that ViiV Healthcare has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal …

News

AstraZeneca’s Soliris given EU CHMP recommendation for marketing authorisation

June 26, 2023
Medical Communications AstraZeneca, CHMP, EMA, Immunology, soliris

UK-based biopharmaceutical company AstraZeneca has announced that the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) …

News

Novartis Cosentyx® gains positive CHMP opinion for hidradenitis suppurativa

April 27, 2023
Business Services CHMP, Cosentyx, Dermatology, Novartis

Basel, April 26, 2023 — Novartis announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European …

News
Press release
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CHMP issue positive opinion for Incyte and MorphoSys’ tafasitamab

June 29, 2021
Manufacturing and Production CHMP, EMA, EU, FDA, US

Incyte and MorphoSys have announced that the EMA’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive …

News

Self-administered Crysvita receives positive CHMP opinion

May 10, 2021
Sales and Marketing CHMP, EMA

Kyowa Kirin’s drug for a rare metabolic bone disease, Crysvita, has received a positive opinion from the EMA’s Committee for …

News
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LEO Pharma receives positive CHMP opinion for dermatitis treatment

April 26, 2021
Sales and Marketing CHMP, EMA, EU, dermatitis

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion …

News

Janssen’s multiple sclerosis treatment recommended by EMA

March 29, 2021
Sales and Marketing CHMP, EMA, Janssen, Johnson & Johnson, PONVORY, multiple sclerosis

Janssen’s PONVORY therapy for the treatment of adults with relapsing forms of multiple sclerosis (MS) has been recommended by the …

News
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Pfizer and Merck KGaA secure CHMP recommendation for Bavencio in Europe for first-line maintenance of urothelial carcinoma

December 14, 2020
Sales and Marketing Bavencio, CHMP, EMA, Merck, Pfizer, pharma, urothelial carcinoma

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given its recommendation for …

News
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EMA’s CHMP recommends conditional approval for Kite Pharma’s CAR T therapy for mantle cell lymphoma

October 20, 2020
Manufacturing and Production, Sales and Marketing CAR T, CAR-T, CHMP, EMA, kite pharma, lymphoma

Kite Pharma’s anti-CD19 chimeric antigen receptor (CAR) T cell therapy known as KTE-X19 has received positive recommendation from the EMA’s …

News
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CHMP recommendation for Janssen’s Tremfya in active psoriatic arthritis

October 19, 2020
Sales and Marketing CHMP, EMA, Janssen, Tremfya

Janssen’s interleukin (IL)-23 inhibitor Tremfya (guselkumab) has scored a recommendation from the EMA’s Committee for Medicinal Products for Human Use …

News

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Ardena announces €20m expansion following first GMP approval

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Eli Lilly’s tirzepatide demonstrates efficacy in reducing sleep apnoea severity

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Medincell and AbbVie enter agreement for development of next-generation injectables

April 17, 2024