Blog
RSS FeedPosted by Michael Wonder on 31 Aug 2025
FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease
29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...
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 06 Dec 2025
New resource: understanding Canada’s drug approval and reimbursement pathway
3 December 2025 - Understanding how new oncology and non-oncology drugs move through Canada’s regulatory and drug access pathways can ...
Posted by Michael Wonder on 05 Dec 2025
Agenda for the December 2025 PBAC meeting
5 December 2025 - The agenda for the December 2025 PBAC meeting is now available. ...
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
New data on drug approvals and reimbursement recommendations in Canada
27 November 2025 - We have published new data about Canada’s pharmaceutical landscape, including data about drug submissions filed with ...
Posted by Michael Wonder on 05 Dec 2025
Cheaper multiple sclerosis and rare cancer medicines now on PBS
4 December 2025 - Australians living with multiple sclerosis and rare cancers will now have access to life-changing medicines thanks ...
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 05 Dec 2025
Lecanemab in early Alzheimer's disease: previously unpublished data show no additional benefit
1 December 2025 - Based on previously unpublished data, the IQWiG concludes that lecanemab offers no proven advantage over the existing ...
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
Pre-filled syringe presentation of Byooviz, Samsung Bioepis’ biosimilar to Lucentis (ranibizumab), gains European approval
2 December 2025 - Samsung Bioepis today announced that the EMA’s CHMP has adopted a positive opinion for Byooviz pre-filled syringe, ...
Posted by Michael Wonder on 04 Dec 2025
High risk early breast cancer patients in Quebec left behind by recent INESSS recommendation
3 December 2025 - Quebec has the highest rate of breast cancer in Canada. The Government of Quebec recently endorsed lowering ...