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RSS FeedPosted by Michael Wonder on 28 Aug 2025
European Commission approves Tevimbra as neo-adjuvant/adjuvant NSCLC treatment
27 August 2025 - Final analysis of RATIONALE-315 demonstrates clear overall survival benefit in peri-operative setting in resectable non-small cell lung ...
Posted by Michael Wonder on 27 Aug 2025
Zemcelpro (UM171 cell therapy) receives EC authorisation as the first and only cell therapy for blood cancer patients without access to suitable donor cells
27 August 2025 - ExCellThera announced today the conditional marketing authorisation of Zemcelpro by the European Commission for the treatment of ...
Posted by Michael Wonder on 26 Aug 2025
European Commission authorises twice yearly Yeytuo (lenacapavir) for HIV prevention
26 August 2025 - Accelerated EC decision comes after US FDA approval in June. ...
Posted by Michael Wonder on 25 Aug 2025
European Commission approves tablet formulation of BeOne Medicines’ Brukinsa for all approved indications
21 August 2025 - Tablets will advance treatment simplicity and convenience to meet patient needs across Europe. ...
Posted by Michael Wonder on 21 Aug 2025
Rhythm Pharmaceuticals announces FDA acceptance of sNDA for setmelanotide in acquired hypothalamic obesity
20 August 2025 - US FDA accepts sNDA for filing with priority review; sets PDUFA goal date of 20 December 2025. ...
Posted by Michael Wonder on 20 Aug 2025
Madrigal receives European Commission approval for Rezdiffra (resmetirom) for the treatment of MASH with moderate to advanced liver fibrosis
19 August 2025 - Conditional marketing authorisation is based on positive results from the pivotal Phase 3 MAESTRO-NASH trial demonstrating Rezdiffra ...
Posted by Michael Wonder on 19 Aug 2025
NewAmsterdam announces acceptance of marketing authorisation applications for review by EMA for obicetrapib
18 August 2025 - NewAmsterdam Pharma today announced that the EMA has validated the marketing authorisation application for obicetrapib 10 mg ...
Posted by Michael Wonder on 18 Aug 2025
European Commission grants approval of Ogsiveo
18 August 2025 - Merck KGaA announced today that the European Commission granted marketing authorisation for Ogisiveo (nirogacestat), an oral gamma ...
Posted by Michael Wonder on 18 Aug 2025
Marketing authorisation application for CT001 has been submitted to the EMA for acute pain management in children
14 August 2025 - The marketing authorisation application for CT001 is submitted to the EMA for acute pain management in ...
Posted by Michael Wonder on 31 Jul 2025
EMA CHMP adopts positive opinion recommending authorisation of Moderna's COVID-19 mRNA vaccine targeting the SARS-CoV-2 variant LP.8.1
25 July 2025 - Moderna's updated COVID-19 mRNA vaccine will be available for the 2025-2026 vaccination season, pending a European ...
Posted by Michael Wonder on 29 Jul 2025
BeOne Medicines receives positive CHMP opinion for Tevimbra in neo-adjuvant/adjuvant NSCLC treatment
28 July 2025 - Recommendation based on Phase 3 RATIONALE-315 study, in which Tevimbra demonstrated clinically meaningful and statistically significant improvement ...
Posted by Michael Wonder on 29 Jul 2025
Alteogen receives positive CHMP opinion for aflibercept biosimilar, 'Eyluxvi (ALT-L9)'
28 July 2025 - Upon approval, Eyluxvi will be Alteogen's second biosimilar product, following a Herceptin biosimilar by Alteogen's license ...
Posted by Michael Wonder on 29 Jul 2025
CHMP recommends EU approval of Henlius’ denosumab biosimilar HLX14
28 July 2025 - Shanghai Henlius Biotech announced today that the EMA's CHMP has adopted a positive opinion for HLX14, the ...
Posted by Michael Wonder on 29 Jul 2025
Zevra Therapeutics submits marketing authorisation application to EMA to review arimoclomol for the treatment of Niemann-Pick disease type C
28 July 2025 - Zevra Therapeutics announced the company submitted a marketing authorisation application to the EMA for the evaluation of ...
Posted by Michael Wonder on 26 Jul 2025
Pfizer and BioNTech receive positive CHMP opinion for LP.8.1 adapted COVID-19 vaccine in the European Union
25 July 2025 - Data indicate that the LP.8.1-adapted COVID-19 vaccine confers improved immune response against currently dominant and emerging sub-lineages ...