Blog
RSS FeedPosted by Michael Wonder on 31 Aug 2025
FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease
29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...
Posted by Michael Wonder on 07 Mar 2025
Second consultation launched on NHS funding for Alzheimer's treatments
6 March 2025 - Cost and evidence gaps remain barriers to approving funding in the NHS for donanemab and lecanemab. ...
Posted by Michael Wonder on 07 Mar 2025
Ferring receives Health Canada approval for Rebyota (faecal microbiota, live)
6 March 2025 - A novel first in class microbiome restoration therapy for the prevention of recurrence of C. difficile infection. ...
Posted by Michael Wonder on 07 Mar 2025
scPharmaceuticals announces FDA approval of supplemental new drug application expanding the Furoscix indication to include the treatment of oedema in patients with chronic kidney disease
6 March 2025 - Furoscix is expected to be available for chronic kidney disease patients in April 2025. ...
Posted by Michael Wonder on 07 Mar 2025
Neurotech’s Encelto (revakinagene taroretcel-lwey) approved by the FDA for the treatment of macular telangiectasia type 2
6 March 2025 - Encelto is the first and only FDA approved treatment for macular telangiectasia type 2. ...
Posted by Michael Wonder on 06 Mar 2025
Cemiplimab in combination with platinum-based chemotherapy for the treatment of patients with advanced non-small-cell lung cancer
5 March 2025 - The Department of Health and Social Care has asked the NICE to produce guidance on the ...
Posted by Michael Wonder on 06 Mar 2025
Idebenone for the treatment of patients 12 years of age and older with visual impairment in Leber’s hereditary optic neuropathy (updated draft guidance)
5 March 2025 - NICE has produced additional draft guidance on the use of idebenone in the NHS in England. ...
Posted by Michael Wonder on 05 Mar 2025
Sparsentan for the treatment of patients with primary IgA nephropathy
4 March 2025 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...
Posted by Michael Wonder on 05 Mar 2025
FDA accepts supplemental biologics license application for Roche’s Gazyva/Gazyvaro for the treatment of lupus nephritis
5 March 2025 - The filing application is based on data from the Phase 3 REGENCY study, where Gazyva/Gazyvaro showed superiority ...
Posted by Michael Wonder on 05 Mar 2025
Tevimbra approved in US for first-line treatment of advanced oesophageal squamous cell carcinoma in combination with chemotherapy
4 March 2025 - New indication based on results from a global Phase 3 trial demonstrating significantly improved overall survival ...
Posted by Michael Wonder on 05 Mar 2025
Skyrizi (risankizumab) now available for moderately to severely active ulcerative colitis, expanding AbbVie's portfolio across inflammatory bowel disease
4 March 2025 - Skyrizi is the first IL-23 specific inhibitor approved for both moderate to severe ulcerative colitis and ...
Posted by Michael Wonder on 05 Mar 2025
Obesity management needs medications on PBS: RACGP
4 March 2025 - The college’s new obesity position statement calls for extra funding to treat the complex condition and for ...
Posted by Michael Wonder on 05 Mar 2025
Capricor Therapeutics announces FDA acceptance and priority review of its biologics license application for deramiocel to treat Duchenne muscular dystrophy
4 March 2025 - FDA assigns PDUFA target action date of 31 August 2025. ...
Posted by Michael Wonder on 05 Mar 2025
Celltrion receives US FDA approval for Stoboclo (denosumab-bmwo) and Osenvelt (denosumab-bmwo) biosimilars referencing Prolia and Xgeva
3 March 2025 - The FDA approval is based on robust clinical evidence, which show no clinically meaningful differences from the ...
Posted by Michael Wonder on 04 Mar 2025
Amneal’s BLA submissions for two denosumab biosimilars accepted for review by US FDA
3 March 2025 - Denosumab biosimilar candidates reference Prolia and Xgeva. ...
Posted by Michael Wonder on 04 Mar 2025
Roche Korea’s multiple sclerosis drug scores reimbursement
4 March 2025 - Roche Korea said its multiple sclerosis treatment, Ocrevus (ocrelizumab), started receiving reimbursement from last Saturday. ...