Blog
RSS FeedPosted by Michael Wonder on 17 Feb 2025
Innate Pharma announces US FDA granted breakthrough therapy designation to lacutamab for relapsed or refractory Sézary syndrome
17 February 2025 - Designation is based on TELLOMAK Phase 2 results demonstrating efficacy and a favourable safety profile in patients ...
Posted by Michael Wonder on 17 Feb 2025
Out of pocket getting out of hand - reducing the financial toxicity of rapidly approved drugs
15 February 2025 - In 2023, Teresa was diagnosed with amyotrophic lateral sclerosis. Several months later, her family started a GoFundMe ...
Posted by Michael Wonder on 16 Feb 2025
FDA approves Samsung Bioepis’ Ospomyv, Xbryk (denosumab-dssb), a biosimilar to Prolia and Xgeva
15 February 2025 - Samsung Bioepis’ first endocrinology biosimilar to be approved by the FDA – widening its therapeutic areas and ...
Posted by Michael Wonder on 14 Feb 2025
FDA approves first rapid-acting insulin biosimilar product for treatment of diabetes
14 February 2025 - Agency continues efforts to increase access to insulin treatment options. ...
Posted by Michael Wonder on 14 Feb 2025
FDA approves vimseltinib for symptomatic tenosynovial giant cell tumour
14 February 2025 - Today, the FDA approved vimseltinib (Romvimza, Deciphera Pharmaceuticals), a kinase inhibitor, for adult patients with symptomatic ...
Posted by Michael Wonder on 14 Feb 2025
LIB Therapeutics announces FDA acceptance of biologics license application for lerodalcibep to lower LDL-cholesterol across broad patient population
10 February 2025 - FDA has set a PDUFA target action date of 12 December 2025. ...
Posted by Michael Wonder on 13 Feb 2025
FDA grants fast track designation to PleoPharma's investigational new drug PP-01 for the mitigation of cannabis withdrawal symptoms in patients with cannabis use disorder: a potential first in class treatment
13 February 2025 - Phase 3 preparations underway. ...
Posted by Michael Wonder on 13 Feb 2025
FDA approves Roche’s Evrysdi tablet as first and only tablet for spinal muscular atrophy
12 February 2025 - New tablet formulation may provide greater freedom and independence for people with spinal muscular atrophy thanks ...
Posted by Michael Wonder on 13 Feb 2025
US FDA approves expanded label for Astellas' Izervay (avacincaptad pegol intravitreal solution) for geographic atrophy
12 February 2025 - Izervay dosing approved beyond 12 months. ...
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
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 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
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 ...