Incyte has announced new early-stage clinical data for INCB123667, a highly selective and potential first-in-class CDK2 inhibitor, showing promising results in patients with advanced solid tumors, particularly ovarian cancer. The data were presented during the European Society of Medical Oncology (ESMO) Congress 2024 and later updated during an Incyte investor event, emphasising the potential of […]
The U.S. Food and Drug Administration (FDA) has approved Niktimvo (axatilimab-csfr), an anti-CSF-1R antibody, for treating chronic graft-versus-host disease (GVHD) in patients who have not responded to at least two previous systemic therapies. This approval marks a significant advancement in the treatment options available for both adult and pediatric patients weighing at least 40 kg […]
Incyte (Nasdaq:INCY), an esteemed biopharmaceutical giant, has unveiled compelling expanded findings from its Phase 3 TRuE-AD3 study on the ruxolitinib cream (Opzelura) for treating children (aged ≥2 to <12 years) with atopic dermatitis (AD), the predominant form of eczema. These critical data points were spotlighted in an influential oral presentation at the European Academy of […]
Incyte has secured marketing authorization for Opzelura (ruxolitinib) cream 15mg/g from the European Commission (EC) for non-segmental vitiligo with facial involvement in adults and adolescents, aged 12 years and above. Opzelura is a cream formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib. It has been approved in the European Union (EU) to offer support for repigmentation […]
Opzelura FDA approval for vitiligo : Incyte has secured approval for Opzelura (ruxolitinib) cream 1.5% from the US Food and Drug Administration (FDA) for the topical treatment of nonsegmental vitiligo in adult and pediatric patients, aged 12 and older. Opzelura is a cream formulation of ruxolitinib, which selectively inhibits JAK1/JAK2. Opzelura FDA approval for vitiligo […]
BriaCell Therapeutics has secured the fast track status from the US Food and Drug Administration (FDA) for its lead candidate — Bria-IMT for the treatment of metastatic breast cancer. The US-based clinical-stage biotech company specializes in targeted immunotherapies for cancer. Bria-IMT is a cell-based immunotherapy, which has been designed to preferentially kill tumor cells without […]
Lilly Covid drug trial : Eli Lilly and Company has enrolled the first patient in a phase 3 randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of baricitinib in hospitalized adults with COVID-19. Baricitinib is an oral JAK1/JAK2 inhibitor, which was licensed by Lilly from Incyte. Marketed as OLUMIANT, baricitinib has approval in […]
Innovent Biologics has dosed the first patient in a phase 2 trial of parsaclisib (IBI-376), a novel and selective PI3Kδ inhibitor in follicular lymphoma (FL). The goal of the study being held in China is to assess the efficacy and safety of parsaclisib in patients having recurrent or refractory follicular lymphoma or marginal zone lymphoma […]
Pemazyre FDA approval : US biopharma company Incyte has bagged accelerated approval from the US Food and Drug Administration (FDA) for Pemazyre (pemigatinib) for the treatment of cholangiocarcinoma, a rare type of cancer occurring in the bile ducts. The approval is for adult patients having certain types of previously treated, advanced cholangiocarcinoma. According to the […]
Ruxolitinib coronavirus clinical trial : Incyte revealed that it is working with the US Food and Drug Administration (FDA) to launch the phase 3 RUXCOVID clinical trial to assess the efficacy and safety of ruxolitinib (Jakafi) plus standard-of-care (SoC) in patients with COVID-19 associated cytokine storm syndrome. The ruxolitinib plus standard-of-care will be compared to […]
