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RSS FeedPosted by Michael Wonder on 06 Dec 2024
Positive CHMP opinion for the extension of indication of Palforzia for the treatment of toddlers with confirmed peanut allergy
2 December 2024 - Stallergenes Greer today announced that the CHMP of the EMA provided a positive opinion for the extension ...
Posted by Michael Wonder on 05 Dec 2024
Orphelia Pharma provides update on the regulatory submission of Kizfizo with the EMA
18 November 2024 - Orphelia to seek re-examination following CHMP negative opinion for the treatment of relapsed or refractory high-risk ...
Posted by Michael Wonder on 05 Dec 2024
European Commission approves BeiGene’s Tevimbra for first-line treatment of advanced/metastatic oesophageal squamous cell carcinoma and gastric or gastro-oesophageal junction cancer
27 November 2024 - New indications based on two Phase 3 studies demonstrating statistically significant overall survival benefit for patients ...
Posted by Michael Wonder on 04 Dec 2024
Anavex Life Sciences announces submission of blarcamesine MAA for treatment of Alzheimer’s disease to EMA
26 November 2024 - First marketing authorisation submission for blarcamesine. ...
Posted by Michael Wonder on 04 Dec 2024
Novartis Kisqali receives European Commission approval in a broad population of patients with HR positive/HER2 negative early breast cancer at high risk of recurrence
27 November 2024 - Approval is based on Phase 3 NATALEE data showing Kisqali (ribociclib) plus adjuvant endocrine therapy demonstrated clinically ...
Posted by Michael Wonder on 30 Nov 2024
Nurix Therapeutics receives PRIME designation from the EMA for NX-5948 for the treatment of relapsed or refractory chronic lymphocytic leukaemia
20 November 2024 - Pivotal trials of NX-5948 are planned to initiate in 2025. ...
Posted by Michael Wonder on 28 Nov 2024
European Commission approves Pfizer’s Hympavzi (marstacimab) for the treatment of adults and adolescents with severe haemophilia A or B without inhibitors
20 November 2024 - In the EU, Hympavzi is the first once weekly subcutaneous treatment approved for eligible people living with ...
Posted by Michael Wonder on 18 Nov 2024
Merck receives positive EU CHMP opinion for Keytruda (pembrolizumab) plus chemotherapy as first-line treatment for adult patients with unresectable non-epithelioid malignant pleural mesothelioma
15 November 2024 - Opinion granted based on positive overall survival results from the IND.227/KEYNOTE-483 trial. ...
Posted by Michael Wonder on 18 Nov 2024
Tagrisso recommended for approval in the EU by CHMP for patients with unresectable EGFR mutated lung cancer
18 November 2024 - Recommendation based on LAURA Phase 3 trial results which showed Tagrisso extended median progression-free survival to ...
Posted by Michael Wonder on 18 Nov 2024
AbbVie receives European Commission approval of Elahere (mirvetuximab soravtansine) for the treatment of platinum resistant ovarian cancer
18 November 2024 - VENTANA FOLR RxDx assay, the companion diagnostic to identify ovarian cancer patients eligible for Elahere, also ...
Posted by Michael Wonder on 16 Nov 2024
Bristol Myers Squibb receives positive CHMP opinion for repotrectinib for the treatment of advanced ROS1 positive non-small cell lung cancer and advanced NTRK positive solid tumours
15 November 2024 - Recommendation based on data from registrational TRIDENT-1 and CARE trials, which demonstrated robust responses and durable activity ...
Posted by Michael Wonder on 15 Nov 2024
Bristol Myers Squibb receives positive CHMP opinion for Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adult patients with microsatellite instability–high or mismatch repair deficient metastatic colorectal cancer
15 October 2024 - Opinion based on results from the Phase 3 CheckMate-8HW trial, in which the dual immunotherapy combination ...
Posted by Michael Wonder on 15 Nov 2024
Highlights from the 11-14 November 2024 CHMP meeting
15 November 2024 - The EMA’s CHMP has recommended eight medicines for approval at its November 2024 meeting. ...
Posted by Michael Wonder on 15 Nov 2024
Sandoz receives European Commission approval for Afqlir (aflibercept), further strengthening leading biosimilar portfolio
15 November 2024 - Afqlir (aflibercept) approved to treat various retinal diseases, including neovascular age-related macular degeneration. ...
Posted by Michael Wonder on 15 Nov 2024
Leqembi recommended for treatment of early Alzheimer’s disease
14 November 2024 - After re-examining its initial opinion, EMA’s CHMP has recommended granting a marketing authorisation to Leqembi (lecanemab) ...