Regulatory
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DPI developer Iconovo announced that the company’s ICOcap capsule-based dry powder inhaler ICOcap is now CE marked for use in clinical trials. The ICOcap inhaler is available from the Stevanato Group, which signed a manufacturing,… Read more . . .
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Microbion Corporation said that its pravibismane inhalation suspension for the treatment of lung infections in patients with cystic fibrosis has been granted orphan drug designation by the FDA. Pravibismane inhalation suspension has already been granted… Read more . . .
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Propeller Health announced that the FDA has granted 510(k) clearance for the company’s inhaler monitoring sensor for AstraZeneca’s Symbicort MDI. The Propeller sensor snaps on to the inhaler and connects via Bluetooth to a mobile… Read more . . .
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Cipla said that it has received final approval for an ANDA for its generic version of Bausch’s Migranal dihydroergotamine (DHE) mesylate nasal spray for the treatment of migraine. According to Cipla, this is the company’s… Read more . . .
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The Chinese National Medical Products Administration (NMPA) has approved AstraZeneca’s Bevespi Aerosphere glycopyrronium/formoterol fumarate MDI for the treatment of COPD, the company said. AstraZeneca’s Breztri Aerosphere budesonide/glycopyrronium/formoterol fumarate MDI was approved for the treatment of COPD by… Read more . . .
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Teva Canada said that it has imported a 4-week supply of Salamol salbutamol (albuterol) sulfate MDIs through Teva UK under an interim order by the Minister of Health in response to shortages of the inhalers in Canada caused… Read more . . .
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VistaGen Therapeutics has announced that it is proposing a Phase 2a study of its PH94B aloradine nasal spray for the treatment of patients with adjustment disorder with anxiety caused by the COVID-19 pandemic, subject to approval… Read more . . .
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Verona Pharma says that the FDA’s comments in response to the data from a Phase 2 study of the company’s RPL554 nebulized ensifentrine for the treatment of COPD support moving ahead with a Phase 3… Read more . . .
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Pulmotect said that it plans to initiate two Phase 2 trials of its PUL-042 immunostimulant inhalation solution for the prevention and treatment of COVID-19 within a week after getting the go-ahead from the FDA. In… Read more . . .
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The FDA has approved an IND for a Phase 2 study of GeneOne Life Science’s GLS-1200 nasal spray for the prevention of COVID-19, the company said. According to GeneOne, GLS-1200 stimulates nasal production of nitric… Read more . . .
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