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RSS FeedPosted by Michael Wonder on 03 Dec 2025
FDA grants traditional approval to pirtobrutinib for chronic lymphocytic leukaemia and small lymphocytic lymphoma
3 December 2025 - Today, the FDA granted traditional approval to pirtobrutinib (Jaypirca, Eli Lilly and Company) for adults with ...
Posted by Michael Wonder on 03 Dec 2025
Ionis receives US FDA breakthrough therapy designation for zilganersen for Alexander disease
2 December 2025 - On track to submit new drug application in Q1, 2026. ...
Posted by Michael Wonder on 03 Dec 2025
Sangamo Therapeutics receives US FDA fast track designation for ST-503 for the treatment of small fibre neuropathy
2 December 2025 - Sangamo Therapeutics today announced that the US FDA has granted fast track designation to ST-503, an investigational ...
Posted by Michael Wonder on 03 Dec 2025
Arrowhead Pharmaceuticals receives FDA breakthrough therapy designation for plozasiran in severe hypertriglyceridaemia
2 December 2025 - Arrowhead Pharmaceuticals today announced that the US FDA has granted breakthrough therapy designation to investigational plozasiran as ...
Posted by Michael Wonder on 02 Dec 2025
Baxdrostat new drug application accepted under FDA priority review in the US for patients with hard to control hypertension
2 December 2025 - Submission based on positive BaxHTN Phase 3 trial results which demonstrated statistically significant and clinically meaningful reduction ...
Posted 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
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 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 ...