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RSS FeedPosted 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 ...
Posted by Michael Wonder on 10 Jan 2024
European Commission approves Pfizer’s Talzenna in combination with Xtandi for adult patients with metastatic castration resistant prostate cancer
8 January 2024 - Talzenna is the first and only PARP inhibitor approved in combination with standard of care Xtandi ...
Posted by Michael Wonder on 08 Jan 2024
UCB announces European Commission approval of Rystiggo (rozanolixizumab) for the treatment of adults with generalised myasthenia gravis in Europe
8 January 2024 - Approval of this orphan medicinal product is based on pivotal Phase 3 MycarinG study in generalised ...
Posted by Michael Wonder on 04 Jan 2024
Applied Therapeutics announces MAA validation and NDA submission of govorestat (AT-007) for treatment of classic galactosaemia
3 January 2024 - Submissions are based on positive results from Phase 3 registrational ACTION-Galactosemia Kids study demonstrating consistent long-term ...
Posted by Michael Wonder on 02 Jan 2024
European Medicines Agency validates Bristol Myers Squibb’s application for repotrectinib for the treatment of locally advanced or metastatic ROS1 positive non-small cell lung cancer and NTRK positive solid tumours
2 January 2024 - Application based on data from the registrational TRIDENT-1 and CARE trials showing robust responses and durable activity ...
Posted by Michael Wonder on 28 Dec 2023
Formycon announces EMA acceptance of the MAA for FYB203, a biosimilar candidate to Eylea (aflibercept)
27 December 2023 - Formycon and its license partner Klinge Biopharma announce that the EMA has accepted the marketing authorisation application ...
Posted by Michael Wonder on 23 Dec 2023
Cidara Therapeutics announces European Approval of Rezzayo (rezafungin) for the treatment of invasive candidiasis in adults
22 December 2023 - Approval based on positive results from the pivotal ReSTORE Phase 3 clinical trial and supported by the ...
Posted by Michael Wonder on 22 Dec 2023
Centralised marketing authorisations of generic versions of Tecfidera are revoked by the European Commission
19 December 2023 - Biogen today announced that the European Commission has revoked the centralised marketing authorizations for generic versions ...
Posted by Michael Wonder on 20 Dec 2023
European Commission approves Merck’s Keytruda (pembrolizumab) plus chemotherapy for new first-line indications in advanced HER2 negative gastric or GEJ adenocarcinoma in tumours expressing PD-L1 (CPS ≥1) and advanced biliary tract cancer
18 December 2023 - Keytruda now approved for 26 indications in the EU, including seven in gastro-intestinal cancers. ...