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RSS FeedPosted by Michael Wonder on 14 Nov 2025
ITM announces FDA acceptance of new drug application and PDUFA date for lutetium Lu 177 edotreotide (ITM-11) in gastro-enteropancreatic neuroendocrine tumours
13 November 2025 - 2025 - ITM Isotope Technologies today announced that the US FDA completed its filing review and accepted ...
Posted by Michael Wonder on 14 Nov 2025
Allterum Therapeutics receives FDA fast track designation for 4A10 in acute lymphoblastic leukaemia
11 November 2025 - Allterum Therapeutics today announced that the US FDA has granted fast track designation for its lead program, ...
Posted by Michael Wonder on 13 Nov 2025
PHARMAC to fund alternative treatment for tooth decay
12 November 2025 - PHARMAC will fund silver diamine fluoride for the treatment and prevention of tooth decay from 1 December ...
Posted by Michael Wonder on 13 Nov 2025
FDA approves new interchangeable biosimilar to Perjeta
13 November 2025 - Today, the FDA approved Poherdy (pertuzumab-dpzb, Shanghai Henlius Biologics) as an interchangeable biosimilar to Perjeta (pertuzumab, ...
Posted by Michael Wonder on 13 Nov 2025
FDA approves ziftomenib for relapsed or refractory acute myeloid leukaemia with a NPM1 mutation
13 November 2025 - Today, the FDA approved ziftomenib (Komzifti, Kura Oncology), a menin inhibitor, for adults with relapsed or ...
Posted by Michael Wonder on 13 Nov 2025
Marius Pharmaceuticals expands global footprint with Health Canada approval of Kyzatrex (testosterone undecanoate) CIII capsules
12 November 2025 - Marius Pharmaceuticals today announced that Health Canada has approved Kyzatrex (testosterone undecanoate) CIII capsules. ...
Posted by Michael Wonder on 13 Nov 2025
Cheaper cancer and chronic conditions medicines now on PBS
13 November 2025 - Australians living with cancer and chronic conditions will now have access to life-changing medicine thanks to ...
Posted by Michael Wonder on 12 Nov 2025
Parabilis Medicines receives FDA fast track designation for FOG-001, the first and only direct inhibitor of the β-catenin:TCF interaction for the treatment of desmoid tumours
12 November 2025 - Parabilis Medicines today announced that the US FDA has granted fast track product designation to FOG-001 ...
Posted by Michael Wonder on 12 Nov 2025
Artios receives US FDA fast track designation for alnodesertib in ATM negative metastatic colorectal cancer
24 September 2025 - Artios Pharma today announced that the US FDA granted fast track designation to its ATR inhibitor, ...
Posted by Michael Wonder on 12 Nov 2025
SMC - November 2025 decisions
10 November 2025 - The SMC, which advises on newly licensed medicines for use by NHSScotland, has today published advice ...
Posted by Michael Wonder on 12 Nov 2025
PHARMAC to fund five medicines for multiple sclerosis, breast cancer, eye conditions, and lung cancer
12 November 2025 - New Zealanders living with multiple sclerosis, breast cancer, eye conditions, and lung cancer will benefit from ...
Posted by Michael Wonder on 12 Nov 2025
AstraZeneca’s Imfinzi, Imjudo, and Ultomiris clear reimbursement panel review
7 November 2025 - AstraZeneca's anti-PD-L1 immune checkpoint inhibitor Imfinzi (durvalumab), the anti-CTLA-4 immune checkpoint inhibitor Imjudo (tremelimumab), and the ...
Posted by Michael Wonder on 11 Nov 2025
EMA publishes agenda for 10-13 November 2025 CHMP meeting
10 November 2025 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 10 Nov 2025
Avenzo Therapeutics granted fast track designation for AVZO-1418, a potential best in class EGFR/HER3 bispecific antibody drug conjugate, for the treatment of patients with EGFR mutated TKI pretreated NSCLC
10 November 2025 - Avenzo Therapeutics today announced the US FDA granted fast track designation to AVZO-1418 (DB-1418), a potential ...
Posted by Michael Wonder on 09 Nov 2025
Mark Cuban Cost Plus Drug Company expands access with addition of Starjemza (ustekinumab-hmny) to give patients more power over prescription costs
6 November 2025 - New biosimilar added to portfolio reinforces the company's commitment to transparency and access ...