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RSS FeedPosted by Michael Wonder on 16 Oct 2023
Santhera receives positive CHMP opinion recommending approval of Agamree (vamorolone) for the treatment of Duchenne muscular dystrophy
13 October 2023 - Agamree could become the first drug fully approved by the EMA for the treatment of patients with Duchenne ...
Posted by Michael Wonder on 16 Oct 2023
EU delays approval of Novavax's revised COVID vaccine
16 October 2023 - European Union regulators have delayed a decision to give approval for Novavax's variant-tailored COVID-19 vaccine, the ...
Posted by Michael Wonder on 14 Oct 2023
Intellia Therapeutics receives Priority Medicines (PRIME) designation from the EMA for NTLA-2002, an investigational in vivo CRISPR genome editing treatment for hereditary angioedema
13 October 2023 - Intellia Therapeutics today announced that the EMA has granted Priority Medicine (PRIME) designation to NTLA-2002 for ...
Posted by Michael Wonder on 14 Oct 2023
Amylyx Pharmaceuticals receives negative CHMP opinion on its marketing authorisation application for AMX0035 for the treatment of ALS in the European Union following re-examination process
13 October 2023 - Final decision from the European Commission expected by the end of 2023. ...
Posted by Michael Wonder on 13 Oct 2023
BeiGene receives positive CHMP opinion for Brukinsa (zanubrutinib) in relapsed or refractory follicular lymphoma
13 October 2023 - If approved, Brukinsa will be the first and only BTK inhibitor approved for follicular lymphoma. ...
Posted by Michael Wonder on 13 Oct 2023
Merck receives positive EU CHMP opinion for Keytruda (pembrolizumab) plus chemotherapy as first-line treatment for HER2 negative advanced gastric or gastro-oesophageal junction adenocarcinoma expressing PD-L1 (CPS ≥1)
13 October 2023 - Opinion granted based on positive overall survival results from the Phase 3 KEYNOTE-859 trial. ...
Posted by Michael Wonder on 13 Oct 2023
New treatment option for heavily pre-treated multiple myeloma patients
13 October 2023 - EMA’s CHMP has recommended a conditional marketing authorisation in the European Union for Elrexfio (elranatamab) as a ...
Posted by Michael Wonder on 13 Oct 2023
Astellas receives positive CHMP opinion for Veoza (fezolinetant)
13 October 2023 - Fezolinetant is an investigational non-hormonal treatment for vasomotor symptoms associated with menopause. ...
Posted by Michael Wonder on 13 Oct 2023
Vueway (gadopiclenol) receives positive CHMP opinion
12 October 2023 - The CHMP of the EMA recommended approval of the macrocyclic, high relaxivity Vueway (gadopiclenol) in adults ...
Posted by Michael Wonder on 11 Oct 2023
EMA publishes agenda for 9-12 October 2023 CHMP meeting
9 October 2023 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 11 Oct 2023
Cosmo announces submission of Winlevi to the EMA
10 October 2023 - Submission to EMA is supported and based on the efficacy and safety evidence gathered in two identical, ...
Posted by Michael Wonder on 07 Oct 2023
Janssen submits application to the European Medicines Agency for Rybrevant (amivantamab) in combination with chemotherapy for the first-line treatment of adult patients with advanced non-small cell lung cancer with activating EGFR exon 20 insertion mutations
6 October 2023 - Type II extension of indication application is supported by data from PAPILLON, the first randomised Phase 3 ...
Posted by Michael Wonder on 03 Oct 2023
Formycon and Fresenius Kabi announce EMA acceptance of the marketing authorisation application for FYB202, an ustekinumab biosimilar candidate
29 September 2023 - Formycon and its commercialisation partner Fresenius Kabi today announced that the EMA has accepted the marketing authorisation ...
Posted by Michael Wonder on 30 Sep 2023
Geron announces EMA validation of marketing authorisation application for imetelstat for the treatment of lower risk MDS
29 September 2023 - Geron Corporation today announced that the EMA has validated the marketing authorisation application for imetelstat, a first-in-class ...
Posted by Michael Wonder on 29 Sep 2023
STADA and Calliditas announce the filing for full marketing authorisation of Kinpeygo in the EU
28 September 2023 - Submission to the CHMP for full approval is based on the full two-year data set from the ...