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 13 Feb 2025
NKGen Biotech receives US FDA fast track designation for troculeucel for the treatment of moderate Alzheimer’s disease
12 February 2025 - NKGen Biotech today announced that the US FDA has granted fast track designation for the investigation of ...
Posted by Michael Wonder on 12 Feb 2025
Lundbeck’s potential treatment amlenetug for multiple system atrophy receives fast track designation from the FDA
12 February 2025 - Lundbeck today announced that amlenetug has received fast track designation from the US FDA. ...
Posted by Michael Wonder on 12 Feb 2025
OnCusp Therapeutics receives FDA fast track designation for CUSP06 for the treatment of platinum-resistant ovarian cancer
12 February 2025 - OnCusp Therapeutics today announced that the US FDA has granted fast track designation to CUSP06, a cadherin-6 ...
Posted by Michael Wonder on 12 Feb 2025
FDA approves brentuximab vedotin with lenalidomide and rituximab for relapsed or refractory large B-cell lymphoma
12 February 2025 - On 11 February 2025, the FDA approved brentuximab vedotin (Adcetris, Seagen) in combination with lenalidomide and a ...
Posted by Michael Wonder on 12 Feb 2025
Ganaxolone for the treatment of patients 2 years of age and older with seizures caused by CDKL5 deficiency disorder
12 February 2025 - NICE has published final evidence-based recommendations on the use of ganaxolone (Ztalmy) for the treatment of ...
Posted by Michael Wonder on 12 Feb 2025
Factorial clinical trial designs
15 January 2025 - Clinical trials using factorial designs in which participants receive several randomised interventions simultaneously allow efficient evaluation of ...
Posted by Michael Wonder on 12 Feb 2025
Health Canada approves Merck's Keytruda (pembrolizumab) for the treatment of adult patients with resectable Stage II, IIIA, or IIIB (T3-4N2) non-small cell lung carcinoma (NSCLC) in combination with platinum-containing chemotherapy as neo-adjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery
11 February 2025 - Approval is based on the Phase 3 KEYNOTE-671 trial. ...
Posted by Michael Wonder on 12 Feb 2025
PHARMAC funds medicines for liver, ovarian, and neuroendocrine cancers
12 February 2025 - People with liver, ovarian, and neuroendocrine cancers will have access to more medicines from 1 March ...
Posted by Michael Wonder on 11 Feb 2025
Biohaven announces FDA acceptance and priority review of troriluzole new drug application for the treatment of spinocerebellar ataxia
11 February 2025 - Troriluzole demonstrated a 50-70% slowing of spinocerebellar ataxia disease progression on the primary and secondary outcome measures at ...
Posted by Michael Wonder on 11 Feb 2025
Heart drug Beyonttra (acoramidis) approved in EU for treatment of transthyretin amyloidosis in adults with cardiomyopathy
11 February 2025 - Approval based on positive results from Phase 3 ATTRibute-CM study. ...
Posted by Michael Wonder on 11 Feb 2025
FDA approves mirdametinib for adult and pediatric patients with neurofibromatosis type 1 who have symptomatic plexiform neurofibromas not amenable to complete resection
11 February 2025 - Today, the FDA approved mirdametinib (Gomekli, SpringWorks Therapeutics), a kinase inhibitor, for adult and paediatric patients ...
Posted by Michael Wonder on 11 Feb 2025
Linvoseltamab BLA accepted for FDA review for the treatment of relapsed/refractory multiple myeloma
11 February 2025 - FDA decision expected by 10 July 2025. ...
Posted by Michael Wonder on 11 Feb 2025
Immix Biopharma receives FDA regenerative medicine advanced therapy designation for NXC-201, sterically optimised CAR-T for relapsed/refractory AL amyloidosis
10 February 2025 - FDA RMAT designation follows positive proof of concept US clinical data from the NXC-201 NEXICART-2 clinical trial ...
Posted by Michael Wonder on 11 Feb 2025
Bayer files for approval of extended 6 month treatment interval for Eylea 8 mg in the EU
10 February 2025 - Bayer submitted an application to the EMA to expand treatment intervals of up to 6 months with ...
Posted by Michael Wonder on 11 Feb 2025
Gilead’s breast cancer treatment Trodelvy passes drug reimbursement panel
7 February 2025 - Gilead's triple negative breast cancer treatment Trodelvy (trastuzumab govitecan) had surmounted a significant hurdle for health ...