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CHMP

Showing 15 posts of 110 posts found.

Bristol Myers Squibb receives positive CHMP opinion for Opdivo treatment

April 4, 2025
Research and Development CHMP, Oncology, bristol myers squibb, immunotherapy, lung cancer, opdivo

Bristol Myers Squibb (BMS) has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for …

News

Eplontersen recommended for EU approval by CHMP for treatment of hereditary transthyretin-mediated amyloidosis

October 21, 2024
Research and Development CHMP, EMA, EU, Internal Medicine, gene

Wainzua (eplotersen), produced by AstraZeneca and Ionis, has been recommended for approval in the European Union (EU) by the European …

News

Pierre Fabre Laboratories receives CHMP positive opinion for BRAFTOVI  in combination with MEKTOVI  for the treatment of adult patients with advanced non-small cell lung cancer  NSCLC) with a BRAFV600E mutation

July 29, 2024
Clinical Trial Services BRAF mutation, CHMP, EMA, Oncology, Pierre Fabre Laboratories, colorectal cancer, european studies, non-small cell lung cancer

Pierre Fabre Laboratories has announced a positive opinion from the European Medical Association’s (EMA) Committee for Medicinal Products Human use …

News

CHMP gives positive opinion for Merck’s KEYTRUDA for unresectable or metastatic urothelial carcinoma

July 29, 2024
Research and Development ADC, CHMP, Merck, Oncology, Urology, keytruda, metastatic urothelial carcinoma, unresectable urothelial carcinoma

Merck (known as MSD outside of the US and Canada) has announced that its anti-PD-1 therapy, in combination with Padcev …

News

AbbVie’s Tepkinly gains positive CHMP opinion for follicular lymphoma treatment

June 28, 2024
Medical Communications AbbVie, CHMP, EMA, Oncology, follicular lymphoma

AbbVie has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has granted a …

News

CHMP recommends AstraZeneca’s Tagrisso for approval for lung cancer treatment

June 3, 2024
Medical Communications CHMP, EMA, Oncology, Tagrisso, lung cancer

AstraZeneca has announced that Tagrisso (osimertinib) alongside pemetrexed and platinum-based chemotherapy, has been recommended for approval in the EU for …

News

J&J gains positive CHMP opinion for Rybrevant for treatment of lung cancer

April 29, 2024
Medical Communications CHMP, EMA, J&J, Oncology, Rybrevant, lung cancer

Janssen, a Johnson & Johnson (J&J) company, has announced that the Committee for Medicinal Products for Human Use (CHMP) of …

News

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
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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 …

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
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