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FDA declines approval of United Therapeutics’ Tyvaso after inspection issue CPhIonline
October 22, 2021
The US Food and Drug Administration has declined to approve United Therapeutics’ Tyvaso (Treprostinil) dry powder inhalation drug-device combination treatment for pulmonary arterial hypertension...
NRx and MannKind to develop Zyesami inhaler for respiratory ailments pharmaceutical-technology
August 05, 2021
NRx Pharmaceuticals has entered an agreement with MannKind to create a dry powder formulation of its investigational drug, Zyesami (aviptadil), for the treatment of various respiratory ailments.
MannKind and United Therapeutics NDA for Tyvaso DPI™ Accepted by U.S. FDA americanpharmaceuticalreview
June 18, 2021
MannKind Corporation and United Therapeutics Corporation announced that the U.S. FDA accepted for priority review the New Drug Application (NDA) for Tyvaso DPI™ (inhaled treprostinil) for the treatment of pulmonary arterial hypertension (PAH) and ...
Covid-19: MannKind, Pneumagen conduct research pharmaceutical-technology
March 19, 2020
MannKind has shifted the research and development (R&D) resources allotted for its lung diseases pipeline to help fight respiratory viral infections, including Covid-19.
Mannkind's Afrezza Facebook page gets slapped by FDA's promo police fiercepharma
October 19, 2018
Mannkind is in hot water for its Afrezza Facebook page. The FDA's Office of Prescription Drug Promotion chastised the pharma for failing to mention the inhaled insulin's risks, citing claims that included Afrezza "will help ...
Deals this week: Olon SpA, MannKind, Shire pharmaceutical-technology
September 11, 2018
Olon SpA has agreed to purchase an active pharmaceutical ingredient (API) manufacturing plant located in Mahad, India, from Novartis for an undisclosed sum.
MannKind signs distribution deal with Tanner for diabetes drug pharmaceutical-technology
August 01, 2018
US-based therapeutic products developer MannKind has signed an agreement with Tanner Pharma Group for the distribution of its Afrezza Inhalation Powder in countries outside the US.
Cipla partners with MannKind for Afrezza – inhaled insulin expressbpd
May 11, 2018
Cipla has entered into an exclusive marketing and distribution agreement with US-based MannKind Corporation for Afrezza in India. It is the only USFDA approved inhaled insulin available for patients suffering from diabetes.
MannKind plots trial pairing inhaled insulin Afrezza with One Drop's digital diabetes manager fiercepharma
August 15, 2017
The MannKind-One Drop test will pair the inhaled insulin Afrezza with a One Drop program that includes its mobile app, an expert coaching service and its Bluetooth custom glucose monitoring meter called Chrome.