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RSS FeedPosted 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 21 Dec 2023
Janssen submits marketing authorisation application to the EMA seeking approval of lazertinib, in combination with Rybrevant (amivantamab), for the first-line treatment of patients with EGFR mutated non-small-cell lung cancer
21 December 2023 - The submission is supported by data from the Phase 3 MARIPOSA study, which featured in a Late-Breaking ...
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. ...
Posted by Michael Wonder on 19 Dec 2023
Artificial intelligence workplan to guide use of AI in medicines regulation
18 December 2023 - The EMA and the Heads of Medicines Agencies have published an artificial intelligence workplan to 2028, ...
Posted by Michael Wonder on 18 Dec 2023
EMA gives positive opinion to Fexinidazole Winthrop as first oral treatment of acute form of sleeping sickness (rhodesiense) found in East and Southern Africa
15 December 2023 - EMA gives positive opinion to Fexinidazole Winthrop as first oral treatment of acute form of sleeping ...
Posted by Michael Wonder on 18 Dec 2023
CHMP issues positive opinion for Biogen’s Skyclarys (omaveloxolone), the first therapy to treat Friedreich’s ataxia, a rare neurodegenerative disease
15 December 2023 - Biogen announced the CHMP of the EMA recommended marketing authorisation for Skyclarys (omaveloxolone) for the treatment ...
Posted by Michael Wonder on 18 Dec 2023
EMA recommends arpraziquantel for treatment of schistosomiasis in pre-school aged children
17 December 2023 - Astellas contributed to the development of a paediatric formulation to treat schistosomiasis as a member of ...
Posted by Michael Wonder on 17 Dec 2023
Takeda receives positive CHMP opinion for Hyqvia as maintenance therapy in patients with chronic inflammatory demyelinating polyneuropathy
15 December 2023 - Positive opinion based on Phase 3 ADVANCE-CIDP 1 study, which met its primary endpoint demonstrating a statistically ...
Posted by Michael Wonder on 16 Dec 2023
Vertex receives CHMP positive opinion for the first CRISPR/Cas9 gene-edited therapy, Casgevy (exagamglogene autotemcel), for the treatment of sickle cell disease and transfusion-dependent beta thalassaemia
15 December 2023 - If approved by the European Commission, patients 12 years of age and older with severe sickle cell ...
Posted by Michael Wonder on 15 Dec 2023
CSL's garadacimab, a first in class factor XIIa inhibitor, receives FDA and EMA filing acceptance
14 December 2023 - These regulatory milestones bring CSL one step closer to delivering on our promise to patients with ...
Posted by Michael Wonder on 14 Dec 2023
Apellis provides update on on-going regulatory review of pegcetacoplan for GA in the European Union
14 December 2023 - Apellis Pharmaceuticals announced today an update on the on-going review of its marketing authorisation application for ...
Posted by Michael Wonder on 13 Dec 2023
First version of the Union list of critical medicines agreed to help avoid potential shortages in the EU
12 December 2023 - The European Commission, the Heads of Medicines Agencies and EMA have published the first version of the ...