MannKind (Nasdaq:MNKD) announced today that it secured $50 million in a private placement and earned a new regulatory nod. In addition to the funding, the company — which also develops inhaled insulin technology — won FDA approval for the Furoscix ReadyFlow auto-injector. MannKind said it entered into a securities purchase agreement in connection with a […]
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The biggest diabetes tech news out of ADA 2026
The biggest names in diabetes tech gathered in New Orleans last weekend for the American Diabetes Association’s 86th Scientific Sessions (ADA 2026). Clinical findings supporting next-generation automated insulin delivery platforms, continuous glucose monitors (CGMs) and all kinds of other technologies were on display in New Orleans. BTIG analysts Marie Thibault, Alexandra Pang and Sam Eiber […]
MannKind shares more data backing inhaled insulin
MannKind (Nasdaq:MNKD) today announced new clinical findings for its Afrezza inhaled insulin powder and Furoscix furosemide injection. The company shared outcomes at the American Diabetes Association Scientific Sessions (ADA 2026) in New Orleans. MannKind’s Afrezza (insulin human) inhalation powder is a fast-acting insulin formulation delivered through an inhaler device. MannKind engineered the mechanical inhaler device to […]
MannKind wins FDA approval for inhaled insulin for children with type 1, type 2 diabetes
MannKind (Nasdaq:MNKD) announced today that it received FDA approval for its Afrezza inhaled insulin powder for children. FDA approval covers use in children and adolescents aged 6 and older with type 1 and type 2 diabetes. Afrezza (insulin human) inhalation powder is a fast-acting insulin formulation delivered through an inhaler device. MannKind engineered the mechanical inhaler […]
MannKind enrolls first patient in study of inhaled insulin for pediatric type 1 diabetes
MannKind (Nasdaq:MNKD) announced today that it enrolled the first patient in the INHALE-1ST study of its Afrezza inhaled insulin. INHALE-1ST evaluates the initiation of Afrezza inhalation powder therapy shortly after type 1 diabetes diagnosis in pediatric patients. Afrezza (insulin human) inhalation powder is a fast-acting insulin formulation delivered through an inhaler device. MannKind engineered the mechanical […]
MannKind earns expanded FDA labeling for inhaled insulin
MannKind (Nasdaq:MNKD) announced today that it received FDA approval for an update to the prescribing information for Afrezza inhaled insulin. Afrezza (insulin human) inhalation powder is a fast-acting insulin formulation delivered through an inhaler device. MannKind engineered the mechanical inhaler device to slowly bring powder into the lung. A small compartment opens for the insertion […]
MannKind earns FDA nod for on-body infusor, new autoinjector patents
MannKind (Nasdaq:MNKD) announced today that the FDA approved its Furoscix (furosemide) on-body infusor for pediatric patients. The company also received additional IP protection for its investigational Furoscix ReadyFlow autoinjector. ReadyFlow remains under FDA review after the agency accepted a supplemental New Drug Application (sNDA) earlier this month. For the on-body infusor, the FDA approved the […]
FDA accepts MannKind sNDA for autoinjector that treats edema
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 […]
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 […]
