The letter makes reference to an ongoing review of inspection findings from a third-party filler involved with the drug development. Regeneron will not require additional trial data.
The treatment, developed by Intercept Pharmaceuticals, could not be approved in its present form, according to the CRL and any resubmission of the treatment for patients with NASH would require at least the successful completion of the long-term outcomes phase of the REGENERATE study.
The FDA's historic June 20, 2023 approval of empagliflozin (Jardiance) and empagliflozin plus metformin hydrochloride (Synjardy) marks the first pediatric type 2 diabetes indication for the SGLT2 inhibitor class and comes less than a year after the debut of DINAMO data.
Announced 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.
On 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.
Announced 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.
Ahead 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.
Ahead of the May 27, 2023 PDUFA date, the HCPLive Cardiology editorial team spoke to a group of cardiologists to capture their perspective of the potential role of sotagliflozin.
The 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.
Announced by Bausch + Lomb and Novaliq, the prescription eye drop for DED is the first and only drop that directly targets tear evaporation, with approval based on results from 2 pivotal phase 3 trials.
The Food and Drug Administration approved the intradermal microdroplet injection, a hydrating gel product designed to smooth out patients’ skin in those over 21 of all Fitzpatrick skin types.
It was announced by ARS Pharmaceuticals, Inc., that a US Food and Drug Administration Drug Advisory Committee voted in favor of a new intranasal epinephrine treatment for severe allergic reactions.
Announced 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.