Blog
RSS FeedPosted by Michael Wonder on 10 Dec 2025
FDA grants breakthrough therapy designation to investigational drug adrabetadex for individuals with infantile onset Niemann-Pick disease type C
9 December 2025 - Breakthrough therapy designation is based on FDA’s review of survival analyses comparing adrabetadex-treated patients with external ...
Posted by Michael Wonder on 08 Dec 2025
Agios provides update on US sNDA for mitapivat in thalassaemia
8 December 2025 - Agios Pharmaceuticals today announced that the US FDA has not yet issued a regulatory decision on the ...
Posted by Michael Wonder on 08 Dec 2025
House passes bill that reauthorises the FDA’s paediatric priority voucher pathway
2 December 2025 - The US House of Representatives has passed a new piece of legislation that reauthorises the US ...
Posted by Michael Wonder on 08 Dec 2025
Incyte’s first in class mutCALR targeted monoclonal antibody, INCA033989, granted breakthrough therapy designation by US FDA
7 December 2025 - Incyte today announced that the US FDA has granted breakthrough therapy designation to INCA033989, a first ...
Posted by Michael Wonder on 07 Dec 2025
FDA approves Omisirge as first approved cell therapy to treat severe aplastic anaemia
5 December 2025 - Ayrmid announces that it has received US FDA approval for Omisirge (Omidubicel-onlv) for the treatment of ...
Posted by Michael Wonder on 05 Dec 2025
FDA to lower number of trials required for approval of drugs, other medical products
4 December 2025 - Shift could speed development but raises concerns about insufficient evidence on efficacy, safety. ...
Posted by Michael Wonder on 05 Dec 2025
Celltrion announces US FDA approval of 300 mg strength of Omyclo (omalizumab-igec), the first and only FDA approved interchangeable biosimilar to Xolair
1 December 2025 - Celltrion today announced the US FDA has approved a new presentation of Omyclo (omalizumab-igec), the first and ...
Posted by Michael Wonder on 04 Dec 2025
Hope Medicine's HMI-115 received US FDA fast track designation, accelerating global development
4 December 2025 - Hope Medicine today announced that its lead pipeline product, HMI-115, a monoclonal antibody targeting the prolactin receptor, ...
Posted by Michael Wonder on 04 Dec 2025
FDA approves lisocabtagene maraleucel for relapsed or refractory marginal zone lymphoma
4 December 2025 - Today, the FDA approved lisocabtagene maraleucel (Breyanzi, Juno Therapeutics, a BMS Company) for adults with relapsed ...
Posted by Michael Wonder on 04 Dec 2025
FDA approves IsoPSA - Cleveland Diagnostics’ novel blood based prostate cancer test
1 December 2025 - Cleveland Diagnostics announced today that the US FDA has approved the company’s IsoPSA in vitro diagnostic ...
Posted by Michael Wonder on 04 Dec 2025
Incannex granted FDA fast track designation for IHL-42X in obstructive sleep apnea
3 December 2025 - Incannex Healthcare announces that the US FDA has granted fast track designation for IHL-42X, the Company’s ...
Posted 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 ...