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RSS FeedPosted 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 ...
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) ...
Posted by Michael Wonder on 19 Feb 2025
European Commission approves Biocon Biologics’ ustekinumab biosimilar
18 February 2025 - Biocon announced today that the European Commission granted marketing authorisation in the European Union for Yesintek, ...
Posted by Michael Wonder on 18 Feb 2025
Welireg (belzutifan) receives first European Commission approval for two indications
18 February 2025 - Welireg is the first and only oral hypoxia-inducible factor-2 alpha inhibitor approved in the European Union ...
Posted by Michael Wonder on 17 Feb 2025
Samsung Bioepis gains European Commission approval for denosumab biosimilar (Obodence, Xbryk)
16 February 2025 - Obodence and Xbryk approved by the European Commission for all indications referencing Prolia and Xgeva, respectively. ...
Posted by Michael Wonder on 16 Feb 2025
Galderma’s Nemluvio (nemolizumab) approved in the European Union for moderate to severe atopic dermatitis and prurigo nodularis
14 February 2025 - This approval from the European Commission is based on robust results from the Phase 3 OLYMPIA and ...
Posted by Michael Wonder on 16 Feb 2025
European Commission approves Egetis’ Emcitate (tiratricol) as the first and only treatment for patients with MCT8 deficiency
13 February 2025 - Egetis Therapeutics today announced that the European Commission has approved Emcitate (tiratricol) for the treatment of ...
Posted by Michael Wonder on 15 Feb 2025
European Commission approves CSL and Arcturus Therapeutics’ Kostaive, the first self-amplifying mRNA COVID-19 vaccine
14 February 2025 - Kostaive represents a significant advancement in vaccine technology, demonstrating superior immunogenicity and antibody persistence for up to ...
Posted by Michael Wonder on 14 Feb 2025
European Commission approves CSL's Andembry (garadacimab) for the prevention of recurrent attacks of hereditary angioedema
13 February 2025 - Supported by the Phase 3 VANGUARD trial, this marks the third regulatory approval for Andembry, which was ...
Posted by Michael Wonder on 11 Feb 2025
Heart drug Beyonttra (acoramidis) approved in EU for treatment of transthyretin amyloidosis in adults with cardiomyopathy
11 February 2025 - Approval based on positive results from Phase 3 ATTRibute-CM study. ...