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RSS FeedPosted by Michael Wonder on 09 Feb 2026
Krystal Biotech announces RMAT designation granted by FDA to KB707 for the treatment of advanced or metastatic non-small cell lung cancer
9 February 2026 - Krystal Biotech announced today that the US FDA granted regenerative medicine advanced therapy designation to KB707, ...
Posted by Michael Wonder on 08 Feb 2026
FDA approves label update for Kite’s Yescarta for relapsed/refractory primary central nervous system lymphoma
6 February 2026 - FDA approves label update for Kite’s Yescarta for relapsed/refractory primary central nervous system lymphoma. ...
Posted by Michael Wonder on 07 Feb 2026
Kisqali receives positive draft recommendation from Canada's Drug Agency for all eligible early breast cancer patients at high risk of recurrence
6 February 2026 - The draft recommendation for Kisqali (ribociclib tablets) from Canada's Drug Agency (CDA-AMC) supports public reimbursement for hormone ...
Posted by Michael Wonder on 05 Feb 2026
PHARMAC proposes wider access to a treatment for people with a rare blood cancer
4 February 2026 - People in New Zealand living with a rare type of blood cancer, systemic anaplastic large cell ...
Posted by Michael Wonder on 05 Feb 2026
Oncolytics Biotech receives FDA fast track designation for pelareorep in second-line KRAS mutant MSS metastatic colorectal cancer
4 February 2026 - Pelareorep now has fast track designation for two gastro-intestinal cancers, solidifying its potential as an immunotherapeutic ...
Posted by Michael Wonder on 05 Feb 2026
Leads Biolabs' GPRC5D/CD3 bispecific T-cell engager LBL-034 earns FDA fast track designation—accelerating launch of potential best in class therapy for relapsed/refractory multiple myeloma
27 January 2026 - Nanjing Leads Biolabs today announced that its key investigational asset LBL-034, a GPRC5D/CD3 bi-specific antibody with a ...
Posted by Michael Wonder on 04 Feb 2026
OS Therapies initiates US FDA BLA filing for OST-HER2 in the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma
2 February 2026 - OS Therapies today announced that it has formally initiated a biologics license application submission to the US ...
Posted by Michael Wonder on 04 Feb 2026
Quebec first province to publicly reimburse Jemperli (dostarlimab for injection) plus chemotherapy via RAMQ for the treatment of all adult patients with primary advanced or first recurrent endometrial cancer
3 February 2026 - GSK announced today that Quebec has become the first Canadian province to publicly reimburse Jemperli (dostarlimab for ...
Posted by Michael Wonder on 03 Feb 2026
Relay Therapeutics announces zovegalisib granted breakthrough therapy designation by US FDA for PIK3CA mutant, HR+/HER2- advanced breast cancer
3 February 2026 - Designation supported by robust clinical data from ReDiscover trial with 600mg BID fasted and 400mg BID fed ...
Posted by Michael Wonder on 03 Feb 2026
Jaypirca (pirtobrutinib), the first and only non-covalent (reversible) BTK inhibitor, now available in Canada for adult patients with relapsed or refractory mantle cell lymphoma and chronic lymphocytic leukaemia
27 January 2026 - The approval of Jaypirca marks Lilly Canada's first haematology launch in Canada. ...
Posted by Michael Wonder on 03 Feb 2026
Health Canada grants authorization for Bayer’s Hyrnuo (sevabertinib) for previously treated patients with locally advanced or metastatic HER2-mutant non-small cell lung cancer
2 February 2026 - Bayer is pleased to announce that Health Canada has authorized Hyrnuo (sevabertinib), oral tablets, for the treatment ...
Posted by Michael Wonder on 03 Feb 2026
Exelixis announces US FDA accepted the new drug application for zanzalintinib in combination with an immune checkpoint inhibitor for patients with metastatic colorectal cancer
2 February 2026 - Exelixis today announced that its new drug application for zanzalintinib, in combination with atezolizumab (Tecentriq), has ...
Posted by Michael Wonder on 03 Feb 2026
Datroway granted priority review in the US as first-line treatment for patients with metastatic triple negative breast cancer who are not candidates for immunotherapy
3 February 2026 - Daiichi Sankyo and AstraZeneca’s supplemental biologics license application for Datroway (datopotamab deruxtecan-dlnk) has been accepted and ...
Posted by Michael Wonder on 02 Feb 2026
Imfinzi perioperative raegimen recommended for approval in the EU by CHMP for patients with early gastric and gastro-oesophageal cancers
2 February 2026 - Recommendation based on MATTERHORN Phase III trial results which showed a 29% reduction in the risk of ...
Posted by Michael Wonder on 01 Feb 2026
New Zealand Pharmaceutical Schedule - 1 February 2026
1 February 2026 - The February 2026 issue of the New Zealand Pharmaceutical Schedule is now available and in effect. ...