CHMP

Showing 15 posts of 99 posts found.

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 …

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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 …

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) …

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 …

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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 …

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 …

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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 …

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 …

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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 …

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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 …

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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 …

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Kyowa Kirin’s Crysvita secures CHMP support in rare X-linked hypophosphataemia

July 28, 2020
Manufacturing and Production, Sales and Marketing CHMP, EMA

The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has given its backing to Kyowa Kirin’s …

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Two CHMP recommendations for AstraZeneca: Imfinzi in first-line lung cancer, Calquence in chronic lymphocytic leukaemia

July 27, 2020
Sales and Marketing AstraZeneca, CHMP, Calquence, EMA, Imfinzi

AstraZeneca has secured two new recommendations for approval of its products from the European Medicines Agency’s Committee for Medicinal Products …

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Positive CHMP approval for Takeda’s Alunbrig in ALK+ advanced non-small lung cancer

March 4, 2020
Research and Development CHMP, EMA, Takeda, lung cancer, pharma

Takeda’s Alunbrig (brigatinib) has been recommended for approval by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human …

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Takeda’s subcutaneous vedolizumab nabs CHMP nod for maintenance of ulcerative colitis and Crohn’s

February 28, 2020
Medical Communications, Sales and Marketing CHMP, EMA, Takeda, vedolizumab

Takeda’s subcutaneous formulation of its gut-selective biologic vedolizumab has secured recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal …

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