Baxter International Inc. announced that the company has submitted a biologics license application (BLA) to the FDA for the approval...
The FDA has given 510(k) clearance for peripheral atherectomy products, Turbo-Tandem and Turbo Elite, from Spectranetics, for the treatment of...
Abbott and Tandem Diabetes Care, Inc. a leading insulin delivery and diabetes technology company, announced that the t:slim X2 insulin pump with Control-IQ technology is the first automated insulin delivery (AID) system to integrate with the newly available FreeStyle Libre 2 Plus sensor, Abbott’s latest continuous glucose monitoring (CGM) technology.
Boston Scientific has entered into a definitive agreement to acquire the interventional radiology portfolio of CeloNova Biosciences, a San Antonio-based...
Fuzeon is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected patients who have received treatment with and failed on regimens containing at least one medicinal product from each of the following antiretroviral classes: protease inhibitors, non-nucleoside reverse transcriptase inhibitors and nucleoside reverse transcriptase inhibitors, or who have intolerance to previous antiretroviral regimens (see section 5.1). In deciding on a new regimen for patients who have failed an antiretroviral regimen, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different medicinal products. Where available, resistance testing may be appropriate (see sections 4.4 and 5.1).
Takeda announced late-breaking data from the Phase III GRAPHITE study presented at the 2023 Tandem Meetings, demonstrating Entyvio (vedolizumab) achieved a statistically significant and clinically meaningful improvement in lower gastrointestinal (GI) Acute Graft-Versus-Host Disease (aGvHD)-free survival by Day 180 after allo-HSCT (Allogeneic Hematopoietic Stem Cell Transplantation) with no relevant differences in safety profile versus placebo
Actinium Pharmaceuticals, Inc reported new analyses from the positive Phase III SIERRA trial of Iomab-B in oral presentations at the at the 2024 Tandem Meetings | Transplantation & Cellular Therapy (TCT) Meetings of ASTCT (American Society for Transplantation and Cellular Therapy and CIBMTR (Center for International Blood and Marrow Transplant Research)
Gilead Sciences, Inc. presented new data reinforcing the efficacy, safety, and tolerability profile of lenacapavir, including patient-reported outcomes (PRO) from the Phase II/III CAPELLA trial
BD (Becton, Dickinson and Company) released findings from a survey conducted by The Harris Poll, between Nov. 14-16, 2022, among 872 U.S. women ages 18 to 64 years old, that indicate a significant gap in women's knowledge about the primary causes of cervical cancer as well as the most effective means of prevention.
FMS-like tyrosine kinase 3- internal tandem duplication (FLT3-ITD) remains as one of the most frequently mutated genes in acute myeloid leukemia (AML), especially in those with normal cytogenetics. The FLT3-ITD and FLT3-TKD...