May 7th 2024
Geneoscopy's ColoSense received FDA approval on May 06, 2024 based on data from the phase 3 CRC-PREVENT trial.
FDA Approves Colchicine Tablets for Reducing Cardiovascular Risk
June 20th 2023Announced by AGEPHA Pharma US on June 20, 2023, the US FDA approval of colchicine 0.5 mg tablets (Lodoco) for reducing cardiovascular event risk marks the first approval in agency history for an anti-inflammatory atheroprotective cardiovascular treatment.
FDA Approves Updated Label for Mavacamten in Obstructive Hypertrophic Cardiomyopathy
June 16th 2023On June 15, 2023, Bristol Myers Squibb announced the FDA approved an updated label for mavacamten (Camzyos) to reflect the agent's ability to reduce the need or eligibility for septal reduction therapy in patients with obstructive HCM based on VALOR-HCM.
FDA Approves Ferric Carboxymaltose Injection for Iron Deficiency in Heart Failure
June 5th 2023Announced in a release by Daiichi Sankyo, Inc. and American Regent, Inc., the therapy is now the first and only intravenous iron replacement therapy indicated for adult patients with heart failure who have iron deficiency.
Exploring the Impact of the Sotagliflozin Approval, with Deepak Bhatt, MD, MPH
May 27th 2023Ahead of the sotagliflozin approval, Deepak Bhatt, MD, MPH, offers perspective into potential future research opportunities for the SGLT1/2 inhibitor and discusses the impact of a 3rd agent boasting SGLT2 inhibition receiving approval for heart failure.
FDA Committee Votes Against Risk-Benefit Profile of OCA 25 mg for NASH
May 20th 2023The June 22, 2023 PDUFA date for obeticholic acid 25 mg oral tablets for the treatment of precirrhotic liver fibrosis appears to be in jeopardy after a May 23, 2023 meeting of the FDA's Gastrointestinal Drugs Advisory Committee.
FDA Expands Dapagliflozin Label to Include Reducing Risk of CV Death in Heart Failure
May 9th 2023Announced just more than a year after AstraZeneca announced topline results, the FDA has approved a label expansion to include reducing cardiovascular death and HF hospitalizations for dapagliflozin based on results of the phase 3 DELIVER trial.
Tirzepatide Achieves Mean Weight Loss of 15.7% in SURMOUNT-2 Trial
April 27th 2023Data from the SURMOUNT-2 trial demonstrate use of tirzepatide 10 mg and 15 mg were associated with mean weight reductions of 13.4% and 15.7%, respectively, with more than 80% of tirzepatide users achieving a body weight reduction of 5% or greater.