MannKind (Nasdaq:MNKD) announced that the FDA accepted a supplemental New Drug Application (sNDA) for its Furoscix ReadyFlow autoinjector. The Furoscix ReadyFlow autoinjector (SCP-111) was developed to deliver a subcutaneous furosemide injection as an investigational alternative to the FDA-approved Furoscix on-body infusion device for treating edema in adult patients with chronic heart failure (CHF) or chronic […]
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FDA accepts application for MannKind inhaled insulin in kids
MannKind (Nasdaq:MNKD) announced today that the FDA accepted a supplemental biologics license for its Afrezza inhaled insulin. The submission, if ultimately approved, would enable MannKind to bring Afrezza to children and adolescents (aged 4-17). Afrezza is a fast-acting insulin formulation delivered through an inhaler device. MannKind engineered the mechanical inhaler device to slowly bring powder […]
MannKind enters cardiometabolic, lung disease drug delivery space with scPharmaceuticals acquisition
MannKind (Nasdaq:MNKD) announced today that it entered into a definitive agreement under which it acquires scPharmaceuticals. The proposed acquisition could deliver MannKind’s strategic expansion into cardiorenal medicine. Danbury, Connecticut-based MannKind already offers inhaled insulin therapy. scPharmaceuticals, meanwhile, markets Furoscix, an FDA-approved on-body unfuser delivering furosemide. Furosemide currently serves as the standard for treating fluid overload […]
MannKind submits inhaled insulin to FDA for pediatrics, inks $500M financing agreement with Blackstone
MannKind (Nasdaq:MNKD) today announced a significant regulatory submission and a large financing agreement with Blackstone. The company submitted its lead inhaled insulin product for expanded FDA approval and secured $500 million in funding, it said. First, the Danbury, Connecticut-based company announced that it submitted a supplemental Biologics License Application (sBLA) for Afrezza, its inhaled insulin […]
The biggest diabetes tech stories out of ADA 2025
The biggest names in diabetes tech gathered in Chicago this past weekend for the American Diabetes Association’s 85th Scientific Sessions. At last year’s edition in Orlando, type 2 diabetes dominated the conversation. This time around, type 2 remained a hot topic, alongside new players in the continuous glucose monitor (CGM) and automated insulin delivery market, […]
Mannkind looks to give those with diabetes another option through inhaled insulin
For those living with diabetes, MannKind offers a very different alternative to the current methods of insulin delivery. Founded in 1991 by Alfred E. Mann, a medtech visionary who played a large part in the wider adoption of insulin pumps as the founder of MiniMed, the company develops Afrezza — a fast-acting insulin formulation delivered […]
Study finds MannKind inhaled insulin safe, effective for children
New study results demonstrated the safety and efficacy of the MannKind Afrezza inhaled insulin offering for children with type 1 diabetes. Investigators presented findings from the INHALE-1 study as a symposium at the American Diabetes Association’s 85th Scientific Sessions. The data showed that inhaled insulin offers a safe and effective replacement for rapid-acting meal insulin […]
MannKind reports positive data for inhaled insulin for children
MannKind today announced six-month results from its Phase 3 INHALE-1 study of Afrezza insulin inhalation powder in children. INHALE-1 looked at Afrezza in children and adolescents between 4-17 years of age. The company expects the data to support an upcoming request for a supplemental new drug application (sNDA) meeting with the FDA. It aims to […]
MannKind has more positive inhaled insulin data
MannKind announced top-level 30-week results from its Phase 4 INHALE-3 study comparing inhaled insulin to traditional delivery methods. The Danbury, Connecticut-based company designed Afrezza, a rapid-acting inhaled human insulin, to improve glycemic control in adults with type 1 diabetes mellitus. The INHALE-3 study looks at Afrezza against usual care. Mannkind defines usual care as multiple […]
The biggest stories from the American Diabetes Association (ADA) 2024 Scientific Sessions
The American Diabetes Association took to Orlando, Florida, the past few days for its 84th Scientific Sessions as optimism grows over diabetes tech. Topics covered included expanding technologies to the type 2 diabetes population (90% of people with diabetes), GLP-1 drugs, automation, broadening user bases and more. The usual big-hitters stepped up to the plate […]
