CYBERMED NEWS - Higher Medical Scientifc Information and Research
CYBERMED NEWS - Higher Medical Scientifc Information and Research
Minutes of the COMP meeting 8-10 September 2026
()
23.Ott.2026
Agenda - Sixth Veterinary Data Stakeholder Forum
()
23.Ott.2026
Highlights - First European Medicines Agency (EMA) - International Society for Cell and Gene Therapy (ISCT) bilateral meeting
()
23.Ott.2026
Minutes of PRAC meeting on 31 August - 3 September 2026
()
23.Ott.2026
CHMP PROM minutes for the meeting on 13 April 2026
()
22.Ott.2026
Ebola
()
24.Ott.2026
Emergency Task Force (ETF) recommendations
()
24.Ott.2026
Position paper on clinical development of Bundibugyo vaccines
()
24.Ott.2026
Media seminar on vaccines, European Medicines Agency, Amsterdam, the Netherlands, from 28 October 2026, 09:00 (CET) to 28 October 2026, 15:30 (CET)
()
23.Ott.2026
Scientific publications
()
23.Ott.2026
Media seminar on vaccines, European Medicines Agency, Amsterdam, the Netherlands, from 28 October 2026, 09:00 (CET) to 28 October 2026, 15:30 (CET)
()
23.Ott.2026
EMA/FVE information session for veterinary students: the importance of pharmacovigilance, Online, European Medicines Agency, Amsterdam, the Netherlands, from 13 October 2026, 16:00 (CEST) to 13 October 2026, 17:15 (CEST)
()
23.Ott.2026
Sixth Veterinary Big Data Stakeholder Forum, European Medicines Agency, Amsterdam, the Netherlands, from 10 November 2026, 09:00 (CET) to 10 November 2026, 17:30 (CET)
()
23.Ott.2026
Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - October 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 21 October 2026, 10:00 (CEST) to 21 October 2026, 12:00 (CEST)
()
23.Ott.2026
Immunogenicity and efficacy of pneumococcal vaccines, Online, European Medicines Agency, Amsterdam, the Netherlands, from 16 November 2026, 09:00 (CET) to 17 November 2026, 17:00 (CET)
()
22.Ott.2026
EMA’s Emergency Task Force (ETF) and the African Medicines Agency (AMA) have published a joint position paper to support the timely start of clinical trials for potential…
()
23.Ott.2026
Six new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended six medicines for approval at its October 2026 meeting.Rasonque (daraxonrasib)…, CHMP statistics Key figures from the October 2026 CHMP meeting are represented in the graphic below. © European Medicines Agency , CHMP statistics:…, Positive recommendations on new medicines, Foundayo International non-proprietary name (INN) orforglipron Marketing authorisation applicant Eli Lilly Nederland B.V. Therapeutic indication Treatment of…, Rasonque INN daraxonrasib Marketing authorisation applicant Revolution Medicines Netherlands B.V. Therapeutic indication Treatment of metastatic pancreatic…, Yuviwel INN navepegritide Marketing authorisation applicant Ascendis Pharma Growth Disorders A/S Therapeutic indication Treatment of achondroplasia in…, Positive recommendations on new biosimilar medicines, Fovlussea INN ranibizumab Marketing authorisation applicant Accord Healthcare S.L.U. Therapeutic indication Treatment of neovascular (wet) age-related macular…, Neuzafy INN filgrastim Marketing authorisation applicant CuraTeQ Biologics (Malta) Limited Therapeutic indication Treatment of neutropenia in adults and…, Positive recommendation on new hybrid medicine, Kizfizo INN temozolomide Marketing authorisation applicant Orphelia Pharma Therapeutic indication Treatment of adults with glioblastoma multiforme and…, Positive recommendations on extensions of therapeutic indications , Kyinsu INN insulin icodec / semaglutide Marketing authorisation holder Novo Nordisk A/S More information Kyinsu: pending EC decision, Pandemic influenza vaccine H5N1 AstraZeneca Common name pandemic influenza vaccine (H5N1) (live attenuated, nasal) Marketing authorisation holder AstraZeneca AB…, Talvey INN talquetamab Marketing authorisation holder Janssen-Cilag International N.V. More information Talvey: pending EC decision Orphan…, Tryngolza INN olezarsen Marketing authorisation holder Swedish Orphan Biovitrum AB (publ) More information Tryngolza: pending EC decision (to be published…, Tukysa INN tucatinib Marketing authorisation holder Pfizer Europe MA EEIG More information Tukysa: pending EC decision, Outcome of re-examination on recommendation for new medicine, Yartemlea INN narsoplimab Marketing authorisation applicant Omeros Ireland Limited Orphan designation This medicine was designated an orphan medicine. More…, Withdrawal of applications for recommendations on extensions of indications, Ibrance INN palbociclib More information Ibrance: questions and answers, Truqap INN capivasertib More information Truqap: questions and answers (to be published shortly), Other updates , Overview of (invented) names reviewed in September 2026 by the Name Review Group (NRG) - Adopted at the CHMP meeting of 15 October 2026Adopted…
()
16.Ott.2026
EMA’s human medicines committee (CHMP) has recommended granting a marketing authorisation in the European Union for Rasonque (daraxonrasib), an oral treatment for adults with…
()
15.Ott.2026
CVMP opinions on veterinary medicinal productsThe Committee adopted a positive opinion, in exceptional circumstances, for a marketing authorisation for Bovilis Lumpyvax (lumpy…
()
09.Ott.2026
The Accelerating Clinical Trials in the EU (ACT EU) advice pilot, which helps sponsors prepare clinical trial applications, will become a permanent initiative from January 2027…
()
08.Ott.2026
Draft Data Quality Framework (DQF) for EU medicines regulation: application to collection, management and submission of Adverse Drug Reaction reports
()
19.Ott.2026
Reflection paper on methodological aspects in confirmatory platform trials
()
19.Ott.2026
Concept paper on the need for revision of the guideline on clinical investigation of medicinal products in the treatment of hypertension (EMA/CHMP/29947/2013/Rev.4)
()
19.Ott.2026
Concept paper on clinical trials in recipients of kidney transplantation
()
16.Ott.2026
Draft reflection paper on the investigation of drug interactions of herbal medicinal products
()
15.Ott.2026
