FDA News

Announced by Tandem Diabetes Care on July 11, 2023, the Tandem Mobi insulin pump is billed as the world's smallest insulin pump, at less than half the size of the t:slim X2 pump and able to fit in a coin pocket.

To celebrate the first half of 2023, we are recapping the top FDA approvals through June 2023 from within the HCPLive Network of brands.

From a novel acne cream to a breakthrough depression drug, a half-dozen agent decisions are coming through in the coming 6 months.

Dr. Juliana Biondo discusses the exciting FDA approval of Roctavian and how it compares with other treatment options like Hemlibra.

Our June 2023 cardiology month in review includes 3 FDA approvals, a primary prevention subgroup analysis of CLEAR Outcomes, and a meta-analysis of 13 major trials examining SGLT2 inhibitor use.

While the FDA decision of Roctavian offers patients with hemophilia A more options, the gene therapy eligibility criteria still pose barriers.

Despite concerns, Dr. Margaret Ragni discusses the significance of the Roctavian's effectiveness for reducing hemophilia A bleeds and improving patient quality of life.

The approval is supported by positive results from the largest and longest phase 3 study for gene therapy in hemophilia, showing a 52% reduction in annualized bleeding rate compared with baseline rates on routine prophylaxis.

Announced on June 28, 2023, the FDA's approval of donislecel (Lantidra) marks the first approval of an allogeneic pancreatic islet cellular therapy for the treatment of type 1 diabetes.

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.