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RSS FeedPosted by Michael Wonder on 29 Aug 2025
Tolremo Therapeutics receives two FDA fast track designations for TT125-802 in pretreated, advanced or metastatic NSCLC with either an EGFR or a KRAS G12C mutation
28 August 2025 - – Tolremo Therapeutics today announced that their lead candidate, TT125-802, received two fast track designations from the ...
Posted by Michael Wonder on 28 Aug 2025
D3 Bio announces FDA breakthrough therapy designation and orphan drug designation for D3S-001 for the treatment of patients with KRAS G12C mutated cancers
28 August 2025 - D3 Bio today announced that the US FDA has granted a breakthrough therapy designation to D3S-001, the ...
Posted by Michael Wonder on 27 Aug 2025
Genmab receives FDA breakthrough therapy designation for rinatabart sesutecan in advanced endometrial cancer
t26 August 2025 - Genmab announced today that the US FDA has granted breakthrough therapy designation to rinatabart sesutecan, an investigational ...
Posted by Michael Wonder on 26 Aug 2025
Allarity Therapeutics granted FDA fast track designation for stenoparib for the treatment of advanced ovarian cancer
26 August 2025 - Allarity Therapeutics today announced that the US FDA has granted fast track designation to stenoparib, its investigational ...
Posted by Michael Wonder on 26 Aug 2025
Enhertu approved in Japan as first HER2 directed medicine for patients with HER2 low or HER2 ultra-low metastatic breast cancer following at least one endocrine therapy
25 August 2025 - Based on DESTINY-Breast06 phase 3 trial results that showed Enhertu demonstrated superiority versus chemotherapy with a ...
Posted by Michael Wonder on 26 Aug 2025
Datroway approved in China for patients with previously treated metastatic HR positive, HER2 negative breast cancer
25 August 2025 - First approval in China for Daiichi Sankyo and AstraZeneca’s Datroway based on TROPIONBreast01 results showing 37% reduction ...
Posted by Michael Wonder on 25 Aug 2025
Bewildering PBAC decision a missed opportunity to ensure Australian cancer patients not left behind
23 August 2025 - MSD Australia & New Zealand is astonished that after eight years of dialogue and consideration, the ...
Posted by Michael Wonder on 25 Aug 2025
Committee rejects application for medication Keytruda to be subsidised for Aussies with cancer
23 August 2025 - Australians with rare cancers like Natalie Willacy have just been handed a devastating hit, which could leave ...
Posted by Michael Wonder on 22 Aug 2025
Breakthrough life-extending combination treatment for advanced bladder cancer recommended by NICE
21 August 2025 - NICE has recommended a new first-line treatment for adults with advanced bladder cancer, marking a significant ...
Posted by Michael Wonder on 20 Aug 2025
Izalontamab brengitecan (EGFRxHER3 ADC) granted breakthrough therapy designation by US FDA for patients with previously treated advanced EGFR mutated non-small cell lung cancer
18 August 2025 - First breakthrough therapy designation in the US for SystImmune and Bristol Myers Squibb’s izalontamab brengitecan based ...
Posted by Michael Wonder on 20 Aug 2025
Health Canada approves dual immunotherapy Opdivo plus Yervoy for colorectal and liver cancers
19 August 2025 - Bristol Myers Squibb Canada today announced that Health Canada has approved Opdivo (nivolumab) in combination with ...
Posted by Michael Wonder on 19 Aug 2025
Iovance’s Amtagvi (lifileucel) receives Health Canada approval for advanced melanoma
18 August 2025 - Iovance Biotherapeutics today announced Health Canada has issued a Notice of Compliance with Conditions for Amtagvi ...
Posted by Michael Wonder on 18 Aug 2025
Ifinatamab deruxtecan granted breakthrough therapy designation by US FDA for patients with pre-treated extensive stage small cell lung cancer
18 August 2025 - First breakthrough therapy designation for Daiichi Sankyo and Merck’s ifinatamab deruxtecan based on IDeate-Lung01 phase 2 ...
Posted by Michael Wonder on 18 Aug 2025
European Commission grants approval of Ogsiveo
18 August 2025 - Merck KGaA announced today that the European Commission granted marketing authorisation for Ogisiveo (nirogacestat), an oral gamma ...
Posted by Michael Wonder on 16 Aug 2025
‘National disgrace’: why Australia is still waiting for proton therapy
15 August 2025 - Teddy Marchmont had to go to Florida, and find $360,000, for the best treatment for his brain ...