Blog
RSS FeedPosted 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 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 ...
Posted by Michael Wonder on 12 Jun 2025
US FDA approves tablet formulation of BeOne’s Brukinsa for all approved indications
11 June 2025 - New formulation provides patients with a simplified dosing experience—reducing pill burden and enhancing ease of administration—while ...
Posted by Michael Wonder on 12 Jun 2025
Health Canada authorises PiaSky (crovalimab for injection) as the first monthly (every four weeks) subcutaneous treatment for people with paroxysmal nocturnal haemoglobinuria
11 June 2025 - Roche Canada is pleased to announce that Health Canada has authorised PiaSky (crovalimab for injection) as ...
Posted by Michael Wonder on 11 Jun 2025
FDA approves taletrectinib for ROS1 positive non-small cell lung cancer
11 June 2025 - Today, the FDA approved taletrectinib (Ibtrozi, Nuvation Bio), a kinase inhibitor, for adults with locally advanced ...
Posted by Michael Wonder on 11 Jun 2025
US FDA approves expanded indication for AbbVie's Mavyret (glecaprevir/pibrentasvir) as first and only treatment for people with acute hepatitis C virus
11 June 2025 - AbbVie today announced that the US FDA approved a label expansion for Mavyret (glecaprevir/pibrentasvir), an oral ...
Posted by Michael Wonder on 10 Jun 2025
Zepzelca (lurbinectedin) and atezolizumab (Tecentriq) combination granted US FDA priority review for first-line maintenance treatment of extensive-stage small cell lung cancer
10 June 2025 - Target action (PDUFA) date set for 7 October 2025. ...
Posted by Michael Wonder on 10 Jun 2025
Axsome Therapeutics provides update on the new drug application for AXS-14 for the management of fibromyalgia
9 June 2025 - Axsome Therapeutics today announced it has received a refusal to file letter from the US FDA ...
Posted by Michael Wonder on 10 Jun 2025
Alnylam receives European Commission approval for Amvuttra (vutrisiran) for the treatment of ATTR amyloidosis with cardiomyopathy
9 June 2025 - Decision follows recent authorisations in the US and Brazil. ...
Posted by Michael Wonder on 10 Jun 2025
US FDA approves Merck’s Enflonsia (clesrovimab-cfor) for prevention of respiratory syncytial virus lower respiratory tract disease in infants born during or entering their first RSV season
9 June 2025 - Enflonsia is the first and only RSV preventive option administered to infants using the same dose ...
Posted by Michael Wonder on 10 Jun 2025
Lipocine announces filing of new drug submission for Tlando in Canada
9 June 2025 - New drug submission filed by Lipocine's licensing partner Verity Pharma. ...
Posted by Michael Wonder on 09 Jun 2025
George Medicines announces FDA approval of Widaplik (telmisartan, amlodipine and indapamide), a new single pill combination treatment for hypertension in adults, including initial treatment
9 June 2025 - Commercialisation planning underway with US launch anticipated Q4, 2025. ...
Posted by Michael Wonder on 07 Jun 2025
European Commission approves Duvyzat for the treatment of Duchenne muscular dystrophy
6 June 2025 - The approval is based on Phase 3 EPIDYS trial data that demonstrated meaningful treatment benefits in ambulant ...