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RSS FeedPosted by Michael Wonder on 16 Jun 2025
Aquestive Therapeutics announces FDA acceptance of new drug application and PDUFA date for Anaphylm for the treatment of severe allergic reactions
16 June 2025 - FDA assigns PDUFA target action date of 31 January 2026 ...
Posted by Michael Wonder on 16 Jun 2025
KalVista Pharmaceuticals announces FDA will not meet PDUFA goal date for sebetralstat NDA for hereditary angioedema due to FDA resource constraints
13 June 2025 - Agency indicates anticipated decision within four weeks ...
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 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 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
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 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 05 Jun 2025
Linerixibat new drug application accepted for review by the US FDA for cholestatic pruritus in patients with primary biliary cholangitis
2 June 2025 - GSK today announced the US FDA has accepted for review the new drug application for linerixibat, an ...
Posted by Michael Wonder on 03 Jun 2025
FDA approves darolutamide for metastatic castration-sensitive prostate cancer
3 June 2025 - Today, the FDA approved darolutamide (Nubeqa) for metastatic castration-sensitive prostate cancer (mCSPC). ...
Posted by Michael Wonder on 02 Jun 2025
FDA accepts TransCon CNP NDA for priority review
2 June 2025 - Ascendis Pharma today announced that the US FDA has accepted for priority review its new drug application ...