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RSS FeedPosted 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 25 Aug 2025
Injectable form of Ocrevus for relapsing remitting multiple sclerosis recommended for PBS listing
22 August 2025 - This new form of ocrelizumab is given as an injection under the skin (subcutaneously), takes a much ...
Posted by Michael Wonder on 24 Aug 2025
New Alzheimer’s drug rejected for PBS listing, leaving patients to pay up to $80k a year
23 August 2025 - New Alzheimer’s drug rejected for PBS listing, leaving patients to pay up to $80k/year. ...
Posted by Michael Wonder on 22 Aug 2025
DoH publishes revised agenda for November 2025 PBAC meeting (version 2)
20 August 2025 - The DoH has published a revised agenda for the November 2025 PBAC meeting. ...
Posted by Michael Wonder on 22 Aug 2025
Leqvio advances toward broader access with agreement between Novartis and the pan-Canadian Pharmaceutical Alliance
21 August 2025 - Eligible Canadian patients with heterozygous familial hypercholesterolaemia are one step closer to publicly funded access to ...
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 22 Aug 2025
Health Canada grants marketing authorisation for an additional indication of Bayer's Nubeqa (darolutamide) for the treatment of metastatic castration-sensitive prostate cancer
21 August 2025 - Bayer is pleased to announce that Health Canada has granted marketing authorisation for its oral androgen receptor ...
Posted by Michael Wonder on 21 Aug 2025
Japan’s PMDA had shortest review times for new drugs, half of drugs submitted to US first
20 August 2025 - According to a recent analysis, Japanese regulators have the shortest time to approval for new drugs compared ...
Posted by Michael Wonder on 21 Aug 2025
Stealth BioTherapeutics announces FDA acceptance of elamipretide NDA resubmission
21 August 2025 - - Stealth BioTherapeutics announced today that the US FDA has accepted for review the resubmission of the ...
Posted by Michael Wonder on 21 Aug 2025
Dawnzera (donidalorsen) approved in the US as first and only RNA targeted prophylactic treatment for hereditary angioedema
21 August 2025 - Offers longest dosing option for hereditary angioedema, with dosing every 4 or 8 weeks. ...
Posted by Michael Wonder on 21 Aug 2025
Rhythm Pharmaceuticals announces FDA acceptance of sNDA for setmelanotide in acquired hypothalamic obesity
20 August 2025 - US FDA accepts sNDA for filing with priority review; sets PDUFA goal date of 20 December 2025. ...
Posted by Michael Wonder on 21 Aug 2025
BioAegis Therapeutics awarded second FDA fast track designation for recombinant human gelsolin to treat inflammasome driven decompression sickness
20 August 2025 - Second fast rrack designation in recent months highlights broad potential of rhu-pGSN across multiple diverse inflammation-driven ...
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
Eylea HD (aflibercept) injection 8 mg applications for expanded US label and pre-filled syringe receive FDA review period extension
20 August 2025 - Regeneron Pharmaceuticals today announced that the US FDA has extended the target action dates to the fourth ...
Posted by Michael Wonder on 20 Aug 2025
Aldeyra Therapeutics receives fast track designation for ADX‑2191 for the treatment of retinitis pigmentosa
19 August 2025 - 025-- Aldeyra Therapeutics today announced that the US FDA has granted fast track designation for ADX-2191 (methotrexate ...