News
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According to Arcturus Therapeutics, the FDA has cleared an investigational new drug application allowing the company to proceed with a Phase 2 MAD trial of its ARCT-032 inhaled mRNA therapy in people with cystic fibrosis.… Read more . . .
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The Medicon Valley Inhalation Consortium (MVIC) announced that marketing specialist Mats Håkansson will take over the CEO role from Lars Asking. According to the announcement, Asking, who had served as the CEO of MVIC since 2017,… Read more . . .
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ENA Respiratory announced that it has completed a Phase 1a study and has initiated a Phase 1b study of its INNA-051 TLR2/6 agonist pan-viral nasal powder in people aged 60 and older. Earlier this year,… Read more . . .
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ARS Pharmaceuticals announced that the European Commission has approved the company’s EURneffy adrenaline nasal spray for the treatment of anaphylaxis. The approval comes soon after the FDA’s approval of the US version, Neffy epinephrine nasal spray. The EMA’s Committee… Read more . . .
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Soon after the FDA granted temporary approval to Liquidia’s sNDA for Yutrepia treprostinil DPI, the company announced that it has filed a lawsuit challenging the FDA’s grant of 3-year new clinical investigation exclusivity to United… Read more . . .
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Pharma Nordic has expanded its distribution agreement with Altamira Medica for Bentrio nasal spray, adding Sweden and Denmark, the companies announced. Bentrio is an OTC bentonite-based nasal spray gel marketed for the prevention and treatment… Read more . . .
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Cessatech and pediatric medicines specialist Proveca have announced a deal that gives Proveca global commercialization rights to Cessatech’s CT001 sufentanil / ketamine analgesic nasal spray. Earlier this year, Cessatech initiated a Phase 3 trial of… Read more . . .
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According to Liquidia Corporation, the FDA has granted tentative approval of the company’s sNDA for Yutrepia dry powder treprostinil for inhalation powder to add pulmonary hypertension associated with interstitial lung disease (PH-ILD) as an indication.… Read more . . .
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Avalyn Pharma has initiated a Phase 1b SAD/MAD trial of its AP02 inhaled nintedanib delivered via the PARI eFlow nebulizer in healthy adults, the company said. Avalyn is developing AP02, along with AP01 inhaled pirfenidone, for… Read more . . .
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The FDA has approved ARS Pharmaceutical’s NDA for Neffy epinephrine nasal spray for the treatment of Type 1 allergic reactions, including anaphylaxis, in patients who weigh 30 kg or greater. In response, ARS Pharma announced that… Read more . . .
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