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RSS FeedPosted by Michael Wonder on 14 Dec 2024
First treatment for peripheral thyrotoxicosis in patients with Allan-Herndon-Dudley syndrome
13 December 2024 - Emcitate can be used in patients of all ages. ...
Posted by Michael Wonder on 14 Dec 2024
First treatment recommended for rare progressive lung conditions in children and adolescents
13 December 2024 - The EMA has recommended extending the indication of Ofev (nintedanib) to include the treatment of progressive ...
Posted by Michael Wonder on 14 Dec 2024
First medicine to treat rare genetic disorder causing cysts and tumours
13 December 2024 - Oral medicine to treat two different conditions, rare von Hippel-Lindau disease and advanced clear cell renal cell ...
Posted by Michael Wonder on 14 Dec 2024
Highlights from the 9-12 December 2024 CHMP meeting
13 December 2024 - The EMA’s CHMP recommended seventeen medicines for approval at its December 2024 meeting. ...
Posted by Michael Wonder on 14 Dec 2024
Roche’s Vabysmo pre-filled syringe approved in the EU for three retinal conditions that can cause blindness
13 December 2024 - Vabysmo PFS is the first and only pre-filled syringe containing a bi-specific antibody, offering a convenient alternative ...
Posted by Michael Wonder on 13 Dec 2024
Lilly's Omvoh (mirikizumab) recommended by CHMP for approval in the European Union for adults with moderately to severely active Crohn's disease
13 December 2024 - The Phase 3 VIVID-1 trial evaluated the safety and efficacy of Omvoh in patients with or without ...
Posted 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
GSK’s fully liquid Menveo meningococcal vaccine approved by European Commission
27 November 2024 - New fully liquid presentation means reconstitution is not needed before use. ...
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
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 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 ...