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RSS FeedPosted by Michael Wonder on 05 Sep 2025
Agios provides update on US PDUFA goal date for Pyrukynd (mitapivat) in thalassemia
4 September 2025 - Agios Pharmaceuticals today announced that the US FDA has extended the PDUFA goal date for the supplemental ...
Posted by Michael Wonder on 04 Sep 2025
Lilly's olomorasib receives US FDA's breakthrough therapy designation for the treatment of certain newly diagnosed metastatic KRAS G12C-mutant lung cancers
4 September 2025 - The breakthrough therapy designation for olomorasib is based on data from the Phase 1/2 LOXO-RAS-20001 trial and ...
Posted by Michael Wonder on 04 Sep 2025
FDA grants Hernexeos breakthrough therapy designation for first-line use in HER2 mutant advanced NSCLC
3 September 2025 - Breakthrough therapy designation is based on results from the Beamion-LUNG 1 clinical trial evaluating Hernexeos (zongertinib tablets) ...
Posted by Michael Wonder on 04 Sep 2025
Achieve Life Sciences announces FDA acceptance of cytisinicline new drug application for treatment of nicotine dependence for smoking cessation
3 September 2025 - Achieve Life Sciences today announced that the US FDA has accepted the cytisinicline new drug application for ...
Posted by Michael Wonder on 03 Sep 2025
Menarini Group's obicetrapib and obicetrapib/ezetimibe marketing authorisation applications accepted for review by the EMA for the treatment of adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia
2 September 2025 - Menarini today announced that EMA has validated the marketing authorisation application for obicetrapib, a selective cholesteryl ...
Posted by Michael Wonder on 03 Sep 2025
FDA accepts Shionogi’s ensitrelvir NDA as the first oral therapy for the prevention of COVID-19 following exposure
2 September 2025 - Shionogi announced the US FDA has accepted a new drug application for ensitrelvir fumaric acid, an investigational ...
Posted by Michael Wonder on 03 Sep 2025
Rolling sBLA initiated to the US FDA for Leqembi Iqlik (lecanemab-irmb) as a subcutaneous starting dose for the treatment of early Alzheimer's disease under fast track status
3 September 2025 - BioArctic partner Eisai announced today that they have initiated a rolling submission of the supplemental biologics license ...
Posted by Michael Wonder on 03 Sep 2025
ICER publishes final evidence report on treatments for spinal muscular atrophy
2 September 2025 - Independent appraisal committee votes reflect uncertainty in net health benefit for apitegromab and for add-on treatments ...
Posted by Michael Wonder on 03 Sep 2025
'More than my rent': NSW woman's $1000 a month fight for relief
3 September 2025 - Six years ago, Raphaella Kathryn Crosby could barely get out of bed. ...
Posted by Michael Wonder on 03 Sep 2025
Health Canada approves Elahere for certain types of platinum-resistant ovarian cancers
2 September 2025 - Elahere received approval through Health Canada's priority review process, based on data from the pivotal MIRASOL Phase ...
Posted by Michael Wonder on 02 Sep 2025
DoH publishes revised agenda for September 2025 PBAC meeting (version 2)
2 September 2025 - The agenda for the September 2025 PBAC meeting has now been updated. ...
Posted by Michael Wonder on 02 Sep 2025
Multiple myeloma drug Darzalex to get expanded coverage from September
29 August 2025 - Starting in September, reimbursement for the multiple myeloma treatment Darzalex (daratumumab) will be expanded, reducing the ...
Posted by Michael Wonder on 02 Sep 2025
Cost of PBS scripts to be dropped to $25 from January 1 2026
2 September 2025 - Prescriptions listed on the PBS will be cut from $31.60 to $25 from January 1, 2026, ...
Posted by Michael Wonder on 01 Sep 2025
Care for people with rare and less common cancers ‘delayed and fragmented’, new report reveals
1 September 2025 - A national survey of nearly 2,500 people affected by cancer has found those with a rare ...
Posted by Michael Wonder on 01 Sep 2025
More cheaper medicines now available for Australians
1 September 2025 - From today, Australians with paediatric psoriasis, fibrodysplasia, asthma, cystic fibrosis and blood cancer now have access ...