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RSS FeedPosted by Michael Wonder on 02 Dec 2025
MannKind announces US FDA accepts for review its supplemental new drug application of Furoscix ReadyFlow Auto-injector for the treatment of oedema in adults with chronic heart failure or chronic kidney disease
1 December 2025 - MannKind Corporation today announced that the US FDA has accepted the sNDA seeking approval for Furoscix ReadyFlow ...
Posted by Michael Wonder on 02 Dec 2025
Solid Biosciences receives FDA rare paediatric disease designation for SGT-212 dual route of administration gene therapy for Friedreich’s ataxia
1 December 2025 - Solid Biosciences today announced that it received rare paediatric disease designation from the US FDA for SGT-212, ...
Posted by Michael Wonder on 02 Dec 2025
Samsung Bioepis announces launch of denosumab biosimilars, Obodence and Xbryk in Europe
1 December 2025 - Samsung Bioepis today announced the launch of Obodence (60 mg pre-filled syringe) and Xbryk (120 mg vial), ...
Posted by Michael Wonder on 02 Dec 2025
Health Canada and the FDA collaborate on generic drug information sharing initiative
1 December 2025 - Health Canada's Pharmaceutical Drugs Directorate and the US FDA Office of Generic Drugs have created a program ...
Posted by Michael Wonder on 02 Dec 2025
EMA validates type II variation application for Padcev (enfortumab vedotin) with Keytruda (pembrolizumab) for certain patients with muscle-invasive bladder cancer
1 December 2025 - Astellas Pharma today announced that the EMA validated for review a type II variation application for ...
Posted by Michael Wonder on 02 Dec 2025
Merck granted fast track designation by the US FDA for MK-2214 for the treatment of Alzheimer's disease
1 December 2025 - MK-2214, an investigational novel antibody targeting phosphorylated serine 413 (pS413) tau. ...
Posted by Michael Wonder on 02 Dec 2025
Ionis receives US FDA breakthrough therapy designation for olezarsen for severe hypertriglyceridaemia
1 December 2025 - On track to submit supplemental new drug application by end of year. ...
Posted by Michael Wonder on 01 Dec 2025
Sound Pharmaceuticals receives FDA breakthrough therapy designation for SPI-1005 to treat Meniere’s disease
1 December 2025 - Sound Pharmaceuticals is pleased to announce that the FDA has granted its investigational new drug, SPI-1005, breakthrough ...
Posted by Michael Wonder on 01 Dec 2025
Cullinan Therapeutics receives FDA fast track designation for CLN-049, a novel FLT3xCD3 T cell engager, in relapsed/refractory acute myeloid leukemia
1 December 2025 - Cullinan Therapeutics today announced that the US FDA has granted fast track designation to CLN-049 for ...
Posted by Michael Wonder on 01 Dec 2025
Vanda Pharmaceuticals provides regulatory update on tradipitant for motion sickness
28 November 2025 - Vanda Pharmaceuticals today announced updates regarding tradipitant for motion sickness. ...
Posted by Michael Wonder on 01 Dec 2025
Lilly lowers the price of Zepbound (tirzepatide) single-dose vials
1 December 2025 - Eli Lilly announced Zepbound (tirzepatide) single dose vials will now be available at lower prices on LillyDirect, ...
Posted by Michael Wonder on 28 Nov 2025
Utilisation of real world evidence in regulatory approvals for multiple myeloma therapies
27 November 2025 - Multiple myeloma is a rare, incurable haematologic malignancy that demands ongoing innovation in treatment approaches given frequent ...
Posted by Michael Wonder on 28 Nov 2025
Celltrion receives Health Canada approval for Eydenzelt, a biosimilar referencing Eylea (aflibercept 2 mg)
27 November 2025 - The approval is based on the totality of evidence, including analytical, nonclinical, and clinical data from global ...
Posted by Michael Wonder on 27 Nov 2025
Alvotech announces approval of AVT03, a biosimilar to Prolia and Xgeva (denosumab) in the European Economic Area
November 24, 2025 - Alvotech today announced that the European Commission has approved AVT03 as a biosimilar to Prolia and ...
Posted by Michael Wonder on 27 Nov 2025
US FDA grants priority review to sonrotoclax for the treatment of relapsed or refractory mantle cell lymphoma
26 November 2025 - BeOne Medicines today announced that the US FDA has accepted and granted priority review to a ...