Blog
RSS FeedPosted by Michael Wonder on 06 Feb 2025
Bayer files for approval of finerenone in heart failure in the EU
3 February 2025 - Regulatory submission is based on positive data from the Phase 3 FINEARTS-HF study presented at ESC Congress ...
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treatment of patients 12 years of age and older with visual impairment in Leber’s hereditary optic neuropathy (updated draft guidance)
5 March 2025 - NICE has produced additional draft guidance on the use of idebenone in the NHS in England.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. ...
Posted by Michael Wonder on 04 Mar 2025
ICER publishes special report on COPD therapies as part of CMS public comment process on Medicare drug price negotiations
3 March 2025 - Report reflects legislative specifications in the Inflation Reduction Act and subsequent CMS guidance. ...
Posted by Michael Wonder on 04 Mar 2025
FDA files Corcept’s new drug application for relacorilant as treatment for patients with hypercortisolism
3 March 2025 - FDA assigns a PDUFA target action date of 30 December 2025. ...
Posted by Michael Wonder on 04 Mar 2025
Qalsody (tofersen injection) receives conditional marketing authorisation from Health Canada as the first ALS treatment targeting a genetic cause
3 March 2025 - Biogen's second rare disease therapy to be approved in Canada reflects a continued commitment to advancing ...
Posted by Michael Wonder on 04 Mar 2025
Depemokimab applications accepted for review by the US FDA for asthma with type 2 inflammation and for chronic rhinosinusitis with nasal polyps
3 March 2025 - Submissions based on data from positive SWIFT and ANCHOR trials. ...
Posted by Michael Wonder on 03 Mar 2025
Latigo Biotherapeutics granted FDA fast track designation for LTG-001, potential best in class Nav1.8 inhibitor for the non-opioid treatment of acute pain
3 March 2025 - LTG-001 demonstrated favourable safety and tolerability profile with predictable pharmacokinetics in Phase 1 trial. ...