Blog
RSS FeedPosted 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
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. ...
Posted by Michael Wonder on 06 Feb 2025
Serplulimab approved in the EU for first-line treatment of extensive-stage small cell lung cancer
5 February 2025 - Serplulimab is the world's first anti-PD-1 monoclonal antibody approved for first-line treatment of extensive stage small-cell lung ...
Posted by Michael Wonder on 04 Feb 2025
CHMP recommends subcutaneous Rybrevant (amivantamab) for the treatment of patients with advanced EGFR mutated non-small cell lung cancer
3 February 2025 - Data from the Phase 3 PALOMA-3 study showed non-inferiority to intravenous administration meeting both co-primary pharmacokinetic endpoints, ...
Posted by Michael Wonder on 03 Feb 2025
Imfinzi recommended for approval in the EU by CHMP as first and only immunotherapy for limited-stage small cell lung cancer
3 February 2025 - Recommendation based on ADRIATIC Phase 3 trial results which showed a 27% reduction in the risk ...
Posted by Michael Wonder on 31 Jan 2025
Datopotamab deruxtecan recommended for approval in the EU by CHMP for patients with previously treated metastatic HR positive, HER2 negative breast cancer
31 January 2025 - Recommendation based on TROPION-Breast01 results showing Daiichi Sankyo and AstraZeneca’s datopotamab deruxtecan reduced risk of disease ...
Posted by Michael Wonder on 31 Jan 2025
Bristol Myers Squibb receives positive CHMP opinion for Opdivo (nivolumab) plus Yervoy (ipilimumab) as a first-line treatment option for adult patients with unresectable or advanced hepatocellular carcinoma
31 January 2025 - Recommendation based on results of Phase 3 CheckMate-9DW clinical trial demonstrating statistically significant and clinically meaningful ...
Posted by Michael Wonder on 31 Jan 2025
Bristol Myers Squibb receives positive CHMP opinion for CAR T cell therapy Breyanzi for relapsed or refractory follicular lymphoma
31 January 2025 - Recommendation based on the Phase 2 TRANSCEND FL study in which 97.1% of patients responded to Breyanzi, ...
Posted by Michael Wonder on 31 Jan 2025
Highlights from the 27-30 January 2025 CHMP meeting
31 January 2025 - Eight new medicines recommended for approval; one positive opinion for a medicine intended for use outside the ...
Posted by Michael Wonder on 22 Jan 2025
Sarclisa approved in the EU as the first anti-CD38 therapy in combination with standard of care VRd to treat transplant-ineligible newly diagnosed multiple myeloma
22 January 2025 - Approval is based on positive results from the IMROZ Phase 3 study, demonstrating Sarclisa in combination with ...
Posted by Michael Wonder on 21 Jan 2025
European Commission approves Lazcluze (lazertinib) in combination with Rybrevant (amivantamab) for the first-line treatment of patients with EGFR-mutated advanced non-small cell lung cancer
21 January 2025 - Latest topline data from the Phase 3 MARIPOSA study shows amivantamab plus lazertinib is the first regimen ...