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RSS FeedPosted by Michael Wonder on 03 Mar 2025
Imfinzi-based perioperative regimen recommended for approval in the EU by CHMP for resectable non-small cell lung cancer
3 March 2025 - Recommendation based on AEGEAN Phase 3 trial results which showed Imfinzi reduced the risk of recurrence, ...
Posted by Michael Wonder on 03 Mar 2025
Vertex receives CHMP positive opinion for expanded label for Kaftrio in combination with ivacaftor for people with cystic fibrosis to include rare mutations
28 February 2025 - If approved, approximately 4,000 people with cystic fibrosis in the European Union will be eligible for ...
Posted by Michael Wonder on 02 Mar 2025
Highlights from the 24-27 February 2025 CHMP meeting
28 February 2025 - Four new medicines recommended for approval; another 16 medicines recommended for extension of their therapeutic indications. ...
Posted by Michael Wonder on 02 Mar 2025
Krystal Biotech receives positive CHMP opinion for Vyjuvek for the treatment of dystrophic epidermolysis bullosa
28 February 2025 - EC approval decision anticipated in second quarter of 2025. ...
Posted by Michael Wonder on 01 Mar 2025
Valneva receives EMA’s positive CHMP opinion for adolescent label extension for chikungunya vaccine Ixchiq
28 February 2025 - If granted, Ixchiq will become the first vaccine against the chikungunya virus available in the EU ...
Posted by Michael Wonder on 01 Mar 2025
AbbVie receives positive CHMP opinion for upadacitinib (Rinvoq) for the treatment of adults with giant cell arteritis
28 February 2025 - The positive opinion is based on results from the pivotal Phase 3 SELECT-GCA trial that evaluated the ...
Posted by Michael Wonder on 01 Mar 2025
Lilly's Jaypirca (pirtobrutinib) recommended by CHMP for approval in the European Union for adults with relapsed or refractory chronic lymphocytic leukaemia previously treated with a BTK inhibitor
28 February 2025 - The positive opinion is based on results from the Phase 3 BRUIN CLL-321 trial, recently presented at ...
Posted by Michael Wonder on 01 Mar 2025
Enhertu recommended for approval in the EU by CHMP for patients with HER2 low or HER2 ultra-low metastatic breast cancer following at least one endocrine therapy
28 February 2025 - Recommendation based on DESTINY-Breast06 Phase 3 trial results which showed Enhertu demonstrated superiority versus chemotherapy with ...
Posted by Michael Wonder on 01 Mar 2025
Novartis oral Fabhalta (iptacopan) receives positive CHMP opinion for the treatment of adults living with C3 glomerulopathy
28 February 2025 - If approved, Fabhalta will be the only medicine indicated to selectively target the underlying cause of C3G, ...
Posted by Michael Wonder on 01 Mar 2025
Linvoseltamab recommended for EU approval by the CHMP to treat relapsed/refractory multiple myeloma
28 February 2025 - Regeneron Pharmaceuticals today announced that the EMA's CHMP has adopted a positive opinion recommending conditional marketing ...
Posted by Michael Wonder on 26 Feb 2025
EMA accepts marketing authorisation application for ND0612, an investigational treatment for motor fluctuations in Parkinson’s disease
21 February 2025 - Mitsubishi Tanabe Pharma today announced the EMA has accepted for review the marketing authorisation application for ...
Posted by Michael Wonder on 25 Feb 2025
EMA validates Gilead’s marketing authorisation application and EU-Medicines for all application for twice yearly lenacapavir for HIV prevention
24 February 2025 - One application seeks European Commission authorisation; other application would facilitate availability in low and lower middle income ...
Posted by Michael Wonder on 24 Feb 2025
The EMA has approved an additional subcutaneous administration option for Takhzyro (lanadelumab) for patients aged 12 years and above with recurrent attacks of hereditary angioedema
24 February 2025 - Takhzyro solution for injection in 2 mL pre-filled pen is now approved to facilitate subcutaneous administration in ...
Posted by Michael Wonder on 24 Feb 2025
EMA publishes agenda for 24-27 February 2025 CHMP meeting
24 February 2025 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 21 Feb 2025
Gilead’s seladelpar granted conditional European marketing authorisation for the treatment of primary biliary cholangitis
20 February 2025 - Now approved, seladelpar can provide an important treatment option for people living with the rare liver Disease ...