EMA
EMA selects TrialAssure anonymisation platform for clinical trial documents
July 30, 2026EMA, TrialAssure, clinical trials
TrialAssure has announced that its ANONYMIZE platform has been selected by the European Medicines Agency (EMA) for use as an …
Rethinking oncology trial endpoints with generalised pairwise comparisons
November 4, 2025Research 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) …
NICE issues positive final guidance for treatment of Duchenne Muscular Dystrophy from Santhera
January 29, 2025Sales 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 …
Eplontersen recommended for EU approval by CHMP for treatment of hereditary transthyretin-mediated amyloidosis
October 21, 2024Research 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 …
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, 2024Clinical 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 …
GSK’s application for Blenrep for MM treatment accepted for EMA review
July 19, 2024Medical 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) …
EMA accepts AstraZeneca’s regulatory submission for sipavibart for COVID-19 prevention
July 1, 2024Research 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 …
AbbVie’s Tepkinly gains positive CHMP opinion for follicular lymphoma treatment
June 28, 2024Medical 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 …
GSK’s Jemperli accepted for review by EMA for endometrial cancer treatment
June 24, 2024Medical 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) …
EC grants marketing authorisation to Sobi’s Altuvoct for haemophilia A treatment
June 19, 2024Medical 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 …
CHMP recommends AstraZeneca’s Tagrisso for approval for lung cancer treatment
June 3, 2024Medical 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 …
AbbVie gains positive CHMP opinion for Skyrizi for treatment of UC
May 31, 2024Medical 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 …
J&J gains positive CHMP opinion for Rybrevant for treatment of lung cancer
April 29, 2024Medical 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 …
EC approves Pfizer’s Prevenar 20 to protect paediatric patients against pneumococcal disease
March 13, 2024Research 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 …
EMA validates two applications for datopotamab deruxtecan for cancer treatments
March 4, 2024Medical 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 …
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