Pharmafile Logo
Pharmafocus logo
Advanced Search

EMA

Showing 15 posts of 400 posts found.

Rethinking oncology trial endpoints with generalised pairwise comparisons

November 4, 2025
Research and Development EMA, FDA, Oncology, One2Treat, clinical trials, generalised pairwise comparisons, net treatment benefit, oncology

For decades, oncology trials have been anchored to a familiar set of endpoints. Overall survival (OS) and progression-free survival (PFS) …

Feature

NICE issues positive final guidance for treatment of Duchenne Muscular Dystrophy from Santhera

January 29, 2025
Sales and Marketing Duchenne Muscular Dystrophy, EC, EMA, FDA, Santhera Pharmaceuticals, positive

Santhera Pharmaceuticals has received positive final guidance from the National Institute for Care and Excellence (NICE) for AGAMREE (vamorolone) to …

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

GSK’s application for Blenrep for MM treatment accepted for EMA review

July 19, 2024
Medical Communications Blenrep, EMA, GSK, Oncology

GSK has announced that the European Medicines Agency (EMA) has accepted the marketing authorisation application (MAA) for Blenrep (belantamab mafodotin) …

News

EMA accepts AstraZeneca’s regulatory submission for sipavibart for COVID-19 prevention

July 1, 2024
Research and Development COVID-19, EMA, Infections and infestations, coronavirus

AstraZeneca has announced that the European Medicines Agency (EMA) has accepted its Marketing Authorisation Application (MAA) for sipavibart under the …

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

GSK’s Jemperli accepted for review by EMA for endometrial cancer treatment

June 24, 2024
Medical Communications EMA, GSK, Jemperli, Oncology, endometrial cancer

GSK has announced that the European Medicines Agency (EMA) has accepted the application to expand the use of Jemperli (dostarlimab) …

News

EC grants marketing authorisation to Sobi’s Altuvoct for haemophilia A treatment

June 19, 2024
Medical Communications Altuvoct, EC, EMA, Haematology, haemophilia a, sobi

Sobi has announced that the European Commission (EC) has granted marketing authorisation for Altuvoct (efanesoctocog alfa) for the treatment and …

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

AbbVie gains positive CHMP opinion for Skyrizi for treatment of UC

May 31, 2024
Medical Communications AbbVie, EMA, Gastrointestinal tract, Skyrizi, ulcerative colitis

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

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

EC approves Pfizer’s Prevenar 20 to protect paediatric patients against pneumococcal disease

March 13, 2024
Research and Development EC, EMA, Infections and infestations, Prevnar 20, pneumococcal disease

Pfizer has announced that the European Commission (EC) has granted marketing authorisation for Prevenar 20, the company’s 20-valent pneumococcal conjugate …

News
louis-reed-pwckf7l4-no-unsplash_5

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
The Gateway to Local Adoption Series

Latest content

STADA and Bio-Thera’s Gotenfia receives positive CHMP opinion for autoimmune diseases

December 18, 2025

Norgine enters exclusive licensing agreement with Vir Biotechnology

December 18, 2025

Incyclix appoints Kimberly Blackwell to Board of Directors

December 17, 2025

Hansa Biopharma appoints Max Sakajja as Vice President, General Manager Europe and International

December 17, 2025

GSK’s Exdensur receives MHRA approval for asthma and rhinosinusitis

December 16, 2025