FDA News

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 guidelines contain safety warnings because psychedelic drugs could produce psychoactive effects such as mood, cognitive changes, and hallucinations.

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.

Data from the open-label extension portion of the phase 3 PaTHway trial detail the long-term effects of TransCon PTH use among people with chronic hypoparathyroidism.

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.

The treatment represents the first approval for pediatric patients with functional constipation.

The ongoing shortage of GLP-1 receptor agonists, namely semaglutide, has prompted the US Food and Drug Administration to issue a warning to patients and providers related to use of compounded semaglutide.

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.

The approval for Abrysvo represents the second RSV vaccine approved for adults aged 60 years and older in the last month.

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.

The FDA approval of sotagliflozin (Inpefa) for the treatment of heart failure was announced by Lexicon Pharmaceuticals on May 26, 2023.

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 approval was based on a comprehensive assortment of studies which showed adalimumab-aaty was comparable to the reference product, adalimumab.

The approval was based on data from a pharmacodynamic study which showed nalmefene provided a fast onset of reversal of respiratory depression from the synthetic opioid remifentanil.

The US Food and Drug Administration (FDA) has approved the adalimumab-adbm (Cyltezo) autoinjector pen ahead of the July 1 commercial launch.

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.

The long-awaited FDA approval follows data that demonstrated about 70% wound closure by 6 months in dystrophic epidermolysis bullosa patients treated with B-VEC.

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.

Announced by the US FDA on May 19, 2023, the clearance of the iLet ACE Pump and the iLet Dosing Decision Software, when combined with a compatible CGM, will form the iLet Bionic Pancreas.

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.

The FDA approval comes with supporting data showing the ERT's non-inferiority to agalsidase beta in controlled eGFR decline.

Announced on May 10, 2023, topline results of the phase 2 dose-finding trial for BI 456906 suggests use was associated with reductions in body weight of up to 14.9% during the 46-week study.

Pending FDA approval, RVO would be the third indication for faricimab-svoa in addition to wet age-related macular degeneration and diabetic macular edema.

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.

The announcement resulted from the FDA’s request for manufacturing, administration, and patient monitoring information.

Older adults with comorbidities, including diabetes and chronic heart and lung disease, are at an increased risk of RSV hospitalization and death.

The extended-release injectable suspension treatment represents the first subcutaneous, long-acting formulation of risperidone.