”“our,”“us” or the “Company”), a clinical-stage biotechnology company addressing serious diseases with significant unmet need, today announced that the U.S. Food and Drug Administration (“FDA”) has granted a Type C meeting request to discuss the company’s p...
Dr. Michael Chancellor, Lipella’s Chief Medical Officer, expressed anticipation for advancing the LP-10 program, stating “We are eager to advance our LP-10 program efficiently, and our scheduled FDA meeting in the second quarter of 2024 will play a pivotal role in enhancing the regulat...
In this episode, hosts take a break from the ADCES meeting to discuss the latest news from Medtronic related to their Simplera CGM and their partnership with Abbott. Medtronic Secures FDA Approval for Simplera CGM, Partners with Abbott
In 2008, the US Food and Drug Administration (FDA) issued a guidance to industry statement concerning evaluation of the cardiovascular (CV) safety of new antihyperglycaemic therapies for type 2 diabetes. Fifteen CV outcome trials assessing three novel classes of antihyperglycaemic therapies, DPP-4...
meeting, a revised draft was made available for public comment, after which the consensus document was finalised. The outcomes of this process are also summarised in an algorithm that details the decision path for monitoring of IAb+people regardless of whether they were screened as part of a ...
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/developing-products-weight-management-revision-1 24. Lach-Trifilieff E, Minetti GC, Sheppard K, et al. An antibody blocking activin type II receptors induces strong skeletal muscle hypertrophy and protects from ...
http://www.fda.gov/downloads/Drugs/Guidances/ucm071612.pdf. February 2007. Accessed July 2, 2015. 15. Kolotkin RL, Crosby RD, Kosloski KD, Williams GR. Development of a brief measure to assess quality of life in obesity. Obes Res. 2001;9(2):102-111.PubMedGoogle ScholarCrossref ...
Geron Corporation, a commercial-stage biopharmaceutical company aiming to change lives by changing the course of blood cancer, today announced new analyses presented at the 66 th American Society of Hematology Annual Meeting from the IMerge clinical tria
Prolonged diabetes duration, poor glycemic control, and insulin dependence8,12,32 may reflect a more progressive disease state. As observed in the Look AHEAD study, better glycemic control and short diabetes duration at baseline were associated with a higher probability of meeting optimal care goals...
FDA guidance on antihyperglyacemic therapies for type 2 diabetes: one decade later. Diabetes Obes Metab. 2019;21(5):1073-1078. doi:10.1111/dom.13645PubMedGoogle ScholarCrossref Effect of Linagliptin vs Placebo on Major Cardiovascular Events in High-Risk Adults With Diabetes JAMA Original ...