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RSS FeedPosted by Michael Wonder on 21 Oct 2023
Rezolute receives Priority Medicines (PRIME) eligibility from EMA for enhanced regulatory support of RZ358 in congenital hyperinsulinism
17 October 2023 - PRIME eligibility granted based on key positive data from the Phase 2B (RIZE) study and current ...
Posted by Michael Wonder on 19 Oct 2023
European Commission approves Keytruda (pembrolizumab) as adjuvant treatment for adults with non-small cell lung cancer at high risk of recurrence following complete resection and platinum-based chemotherapy
16 October 2023 - Decision marks fifth approval for Keytruda in lung cancer in the EU. ...
Posted by Michael Wonder on 19 Oct 2023
European Commission approves Adcetris (brentuximab vedotin) for the treatment of adult patients with previously untreated CD30 positive stage III Hodgkin lymphoma in combination with AVD
18 October 2023 - Approval based on updated positive overall survival results from the Phase 3 ECHELON-1 study for stage III ...
Posted by Michael Wonder on 18 Oct 2023
Merck receives positive EU CHMP opinion for Prevymis for prevention of CMV disease in high risk adult kidney transplant recipients and extended 200 day dosing in adult HSCT recipients at risk for late CMV infection and disease
17 October 2023 - Merck today announced that the CHMP of the EMA has recommended the approval of Prevymis (letermovir) for ...
Posted by Michael Wonder on 17 Oct 2023
GSK receives positive CHMP opinion recommending approval of Jemperli (dostarlimab) plus chemotherapy as a new frontline treatment for dMMR/MSI-H primary advanced or recurrent endometrial cancer
16 October 2023 - If approved, dostarlimab would become the first new frontline treatment option in the European Union in ...
Posted by Michael Wonder on 16 Oct 2023
Mundipharma and Cidara Therapeutics receive positive CHMP opinion for rezafungin for the treatment of invasive candidiasis in adults
13 October 2023 - The opinion was based on positive results from the pivotal ReSTORE Phase 3 clinical trial and supported ...
Posted 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 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. ...