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RSS FeedPosted 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 28 Jul 2025
Highlights from the 21-24 July 2025 CHMP meeting
25 July 2025 - The EMA’s CHMP recommended 13 medicines for approval at its July 2025 meeting. ...
Posted by Michael Wonder on 26 Jul 2025
Gilead receives positive CHMP opinions under accelerated review from EMA for twice yearly lenacapavir for HIV prevention
25 July 2025 - Positive opinion also received for EMA’s EU-M4all Procedure, designed to facilitate availability in low- and lower-middle-income countries. ...
Posted by Michael Wonder on 25 Jul 2025
European regulatory authority adopts positive opinion for Novo Nordisk’s Alhemo (concizumab), recommending label expansion to treat haemophilia A and B without inhibitors
25 July 2025 - This positive opinion by the EMA’s CHMP is based on results from the explorer8 trial, which ...
Posted by Michael Wonder on 25 Jul 2025
Trixeo Aerosphere receives positive EU CHMP opinion as first inhaled medicine using next-generation propellant with near-zero Global Warming Potential
25 July 2025 - Next-generation propellant offers 99.9% reduction in global warming potential compared to current propellants. ...
Posted by Michael Wonder on 25 Jul 2025
Donanemab receives positive opinion from the CHMP in early symptomatic Alzheimer's disease
25 July 2025 - Eli Lilly and Company announced today that the EMA's CHMP has issued a positive opinion recommending donanemab ...
Posted by Michael Wonder on 21 Jul 2025
EMA publishes agenda for 21-24 July 2025 CHMP meeting
21 July 2025 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 24 Jun 2025
Ozempic receives EU recommendation in peripheral arterial disease, cementing the broad benefits of semaglutide for people with type 2 diabetes and co-morbidities
23 June 2025 - Pending a decision from the European Commission, Ozempic (once weekly semaglutide) will have the broadest approved label ...
Posted by Michael Wonder on 16 Jun 2025
EMA publishes agenda for 16-19 June 2025 CHMP meeting
16 June 2025 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 25 May 2025
CHMP recommends EU approval of Roche’s Itovebi for PIK3CA mutated, ER positive, HER2 negative, advanced breast cancer
23 May 2025 - Positive recommendation based on Phase 3 INAVO120 data showing Itovebi (inavolisib) in combination with palbociclib and fulvestrant ...
Posted by Michael Wonder on 26 Apr 2025
CHMP recommends approval of Oczyesa for treatment of acromegaly in the EU
25 April 2025 - Camurus today announced that the EMA's CHMP has adopted a positive opinion for market authorisation of Oczyesa, ...
Posted by Michael Wonder on 22 Apr 2025
EMA publishes agenda for 22-25 April 2025 CHMP meeting
22 April 2025 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 03 Apr 2025
Averoa receives positive opinion from the EMA for Xoancyl, an oral therapy for chronic kidney disease
2 April 2025 - Final European Commission decision expected by June 2025; UK regulatory submission foreseen via MHRA’s international recognition procedure. ...
Posted by Michael Wonder on 02 Apr 2025
Sydnexis announces positive CHMP opinion in Europe for SYD-101 for slowing the progression of paediatric myopia
1 April 2025 - Santen is Sydnexis’ licensing partner to commercialise SYD-101 within the EMEA region upon issuance of a ...