Blog
RSS FeedPosted by Michael Wonder on 19 Jun 2025
Final draft guidance finds benefits of two treatments for patients with Alzheimer’s disease remain too small to justify the additional cost to the NHS
19 June 2025 - The benefits from donanemab (Kisunla; Eli Lilly) and lecanemab (Leqembi; Eisai) - remain too small to justify ...
Posted by Michael Wonder on 19 Jun 2025
Tislelizumab for the treatment of adults with advanced non-small-cell lung cancer after platinum-based chemotherapy
19 June 2025 - NICE is unable to make a recommendation on the use of tislelizumab (Tevimbra) for the treatment of ...
Posted by Michael Wonder on 19 Jun 2025
Atezolizumab for the adjuvant treatment of patients with resected non-small-cell lung cancer
19 June 2025 - NICE has published final evidence-based recommendations on the use of atezolizumab (Tecentriq) for the adjuvant treatment ...
Posted by Michael Wonder on 19 Jun 2025
Kye Pharmaceuticals receives Health Canada approval for new dosing guidance for Firdapse and an additional paediatric indication
17 June 2025 - Kye Pharmaceuticals today announced that Health Canada has approved its supplemental new drug submission regarding the recommended ...
Posted by Michael Wonder on 19 Jun 2025
Health Canada approves Novartis' Kisqali for HR positive, HER2 negative early breast cancer patients at high risk of recurrence
18 June 2025 - Health Canada approval is based on the pivotal Phase 3 NATALEE trial data, which demonstrated a clinically ...
Posted by Michael Wonder on 18 Jun 2025
FDA approves tafasitamab-cxix for relapsed or refractory follicular lymphoma
18 June 2025 - Today, the FDA approved tafasitamab-cxix (Monjuvi, Incyte) with lenalidomide and rituximab for adults with relapsed or ...
Posted by Michael Wonder on 17 Jun 2025
US FDA approves CSL's Andembry (garadacimab-gxii), the only prophylactic hereditary angioedema treatment targeting factor XIIa with once monthly dosing for all patients from the start
16 June 2025 - Once monthly dosing reduced HAE attacks by a median of more than 99& and a least squares ...
Posted by Michael Wonder on 17 Jun 2025
Vanflyta is now approved in Canada specifically for adult patients with newly diagnosed FLT3-ITD positive AML
16 June 2025 - Approval based on QuANTUM-First results demonstrating Vanflyta added to chemotherapy improved overall survival ...
Posted by Michael Wonder on 17 Jun 2025
Averoa receives European marketing authorisation for Xoanacyl, an oral therapy for chronic kidney disease
16 June 2025 - AVEROA actively seeking strategic partners and investors to bring Xoanacyl to European patients and unlock full ...
Posted by Michael Wonder on 16 Jun 2025
Celltrion announces US FDA approval of additional presentation of Steqeyma (ustekinumab-stba), expanding dosing options for pediatric patients
15 June 2025 - Approval of 45 mg/0.5 mL solution in a single-dose vial for subcutaneous injection expands dosing flexibility for ...
Posted by Michael Wonder on 14 Jun 2025
Xediton Pharmaceuticals announced today the Canadian approval and availability of Vabomere (meropenem-vaborbactam) in Canada
12 June 2025 - Xediton Pharmaceuticals is proud to announce that Vabomere (meropenem-vaborbactam) has been approved by Health Canada and ...
Posted by Michael Wonder on 14 Jun 2025
Moderna receives US FDA approval for RSV vaccine, mRESVIA, in adults aged 18–59 at increased risk for RSV disease
12 June 2025 - Expanded indication builds on existing US FDA approval of mRESVIA for adults aged 60 and older. ...
Posted by Michael Wonder on 14 Jun 2025
NICE leads the way in approving breakthrough treatment for multiple myeloma
13 June 2025 - People in England will become the first in the world to receive belantamab mafodotin for this indication ...
Posted by Michael Wonder on 12 Jun 2025
FDA approves neo-adjuvant and adjuvant pembrolizumab for resectable locally advanced head and neck squamous cell carcinoma
12 June 2025 - Today, the FDA approved pembrolizumab (Keytruda, Merck) for adults with resectable locally advanced head and neck ...
Posted by Michael Wonder on 12 Jun 2025
FDA approves mitomycin intravesical solution for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer
12 June 2025 - Today, the FDA approved mitomycin intravesical solution (Zusduri, UroGen Pharma) for adult patients with recurrent low-grade ...