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RSS FeedPosted by Michael Wonder on 09 Apr 2025
Bayer files for approval of aflibercept 8 mg for treatment of retinal vein occlusion in EU
8 April 2025 - Bayer has submitted an application to the EMA seeking approval of aflibercept 8 mg (114.3 mg/ml solution ...
Posted by Michael Wonder on 04 Apr 2025
Helsinn submits a new formulation of Akynzeo to the EMA
2 April 2025 - Helsinn today announced the submission of a new formulation for Akynzeo to the EMA. ...
Posted by Michael Wonder on 31 Mar 2025
Calquence plus chemoimmunotherapy recommended for approval in the EU by CHMP as first and only BTK inhibitor for first-line mantle cell lymphoma
31 March 2025 - Recommendation based on ECHO Phase 3 trial results which demonstrated over 16 months of progression-free survival ...
Posted by Michael Wonder on 30 Mar 2025
EMA validates Henlius and Organon filing for Perjeta (pertuzumab) biosimilar candidate HLX11
28 March 2025 - -Shanghai Henlius Biotech and Organon today announced that the EMA has validated the marketing authorisation application for ...
Posted by Michael Wonder on 28 Mar 2025
Crinetics Pharmaceuticals announces EMA validation of marketing authorisation application and orphan drug designation for paltusotine in acromegaly
27 March 2025 - Crinetics Pharmaceuticals today announced that the EMA has validated the marketing authorisation application for paltusotine, the ...
Posted by Michael Wonder on 28 Mar 2025
Richter announces submission to EMA for biosimilar tocilizumab in multiple indications
27 March 2025 - Gedeon Richter announces today that the EMA has accepted Richter’s marketing authorisation application for its proposed biosimilar ...
Posted by Michael Wonder on 26 Mar 2025
FDA grants priority review for biologics license application and EMA accepts marketing authorisation application for apitegromab as a treatment for spinal muscular atrophy
25 March 2025 - FDA to review BLA application under priority review, with a PDUFA date of 22 September 2025. ...
Posted by Michael Wonder on 25 Mar 2025
GSK’s application to expand use of Nucala (mepolizumab) for the treatment of COPD accepted for review by the European Medicines Agency
24 March 2025 - Submission based on data from MATINEE trial, which showed a statistically significant and clinically meaningful reduction in ...
Posted by Michael Wonder on 24 Mar 2025
CStone submits application to the EMA for new indication of sugemalimab in stage III non-small cell lung cancer
23 March 2025 - CStone Pharmaceuticals today announced the submission of a type II variation application to the EMA for sugemalimab. ...
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
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 21 Feb 2025
EMA validates indication extension application for Aspaveli for treatment of C3G and primary IC-MPGN
20 February 2025 - Sobi and Apellis Pharmaceuticals today announced the EMA has validated an indication extension application for Aspaveli (pegcetacoplan) ...