Blog
RSS FeedPosted by Michael Wonder on 06 Feb 2024
Ultragenyx receives PRIME designation from EMA for GTX-102 for the treatment of Angelman syndrome
5 February 2024 - GTX-102 is the first Angelman syndrome therapeutic candidate to receive PRIME designation. ...
Posted by Michael Wonder on 03 Feb 2024
Tisotumab vedotin marketing authorisation application validated by EMA for treatment of recurrent or metastatic cervical cancer
2 February 2024 - Genmab and Pfizer today announced that the EMA has validated for review the marketing authorisation application ...
Posted by Michael Wonder on 02 Feb 2024
Linvoseltamab receives EMA filing acceptance for treatment of relapsed/refractory multiple myeloma
2 February 2024 - Regeneron Pharmaceuticals today announced that the EMA has accepted for review the marketing authorisation application for linvoseltamab ...
Posted by Michael Wonder on 30 Jan 2024
European Commission authorises GSK’s Omjjara (momelotinib)
29 January 2024 - Indicated in both newly diagnosed patients and those previously treated with existing standard of care. ...
Posted by Michael Wonder on 30 Jan 2024
Takeda’s Hyqvia approved by European Commission as maintenance therapy in patients with chronic inflammatory demyelinating polyneuropathy
30 January 2024 - At home or in office administration provides CIDP patients with a personalised treatment experience. ...
Posted by Michael Wonder on 30 Jan 2024
GSK’s RSV vaccine, Arexvy, accepted for regulatory review by the EMA for the prevention of RSV disease in adults aged 50-59 at increased risk
29 January 2024 - Application supported by positive results of a Phase 3 trial showing immune response and acceptable tolerability ...
Posted by Michael Wonder on 27 Jan 2024
Highlights from the 22-25 January 2024 CHMP meeting
26 January 2024 - The EMA’s CHMP recommended three medicines for approval at its January 2024 meeting. ...
Posted by Michael Wonder on 26 Jan 2024
Bristol Myers Squibb receives positive CHMP opinion for CAR T-cell therapy Abecma (idecabtagene vicleucel) in earlier lines of therapy for triple class exposed relapsed and refractory multiple myeloma
26 January 2024 - Recommendation for approval based on Phase 3 KarMMa-3 study in which Abecma demonstrated superiority over standard regimens, ...
Posted by Michael Wonder on 26 Jan 2024
CHMP issues negative opinion for renewal of conditional marketing authorisation for Translarna (ataluren) following re-examination procedure
25 January 2024 - PTC Therapeutics announced today that the CHMP of the EMA issued a negative opinion following the re-examination ...
Posted by Michael Wonder on 26 Jan 2024
European Medicines Agency validates type II variation application for Padcev (enfortumab vedotin) with Keytruda (pembrolizumab) for first-line treatment of advanced bladder cancer
26 January 2024 - Pivotal trial found the enfortumab vedotin plus pembrolizumab combination significantly extended overall and progression-free survival. ...
Posted by Michael Wonder on 22 Jan 2024
EMA publishes agenda for 22-25 January 2024 CHMP meeting
22 January 2024 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 17 Jan 2024
European Commission approves Roche’s Tecentriq SC, the EU's first PD-(L)1 cancer immunotherapy subcutaneous injection for multiple cancer types
16 January 2024 - Roche is working closely with national health systems in Europe to ensure patients can access Tecentriq ...
Posted by Michael Wonder on 16 Jan 2024
Human medicines: highlights of 2023
16 January 2024 - In 2023, EMA recommended 77 medicines for marketing authorisation. ...
Posted by Michael Wonder on 12 Jan 2024
European Commission approves Krazati (adagrasib) as a targeted treatment option for patients with advanced non-small-cell lung cancer with a KRAS G12C mutation
10 January 2024 - Mirati Therapeutics today announced that the European Commission granted conditional marketing authorisation for Krazati (adagrasib) as ...
Posted by Michael Wonder on 11 Jan 2024
STADA and Alvotech secure approval for Uzpruvo, Europe’s first ustekinumab biosimilar to Stelara
10 January 2024 - Approval for the Uzpruvo biosimilar is based on comprehensive package comprising analytical, non-clinical and clinical similarity ...