Medical
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ARS Pharmaceuticals said that it intends to file a response to the September 2023 complete response letter to its NDA for Neffy epinephrine nasal spray “early in the second quarter of 2024,” with the response… Read more . . .
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LTR Pharma has announced the initiation of a bioequivalence study of its Spontan vardenafil nasal spray, which the company is developing for the treatment of erectile dysfunction. According to LTR, the study will compare a… Read more . . .
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Health Canada has announced that Apotex is recalling 2 lots of its mometasone nasal spray, a generic of Nasonex, due to possible contamination with Burkholderia cepacia complex. Lot TX5343 has an expiration date of September 2025, and… Read more . . .
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SaNOtize has initiated a Phase 2 study of its nitric oxide nasal spray (NONS) for the treatment of recurrent acute rhinosinusitis, the company said. The trial is expected to enroll 186 patients who will receive… Read more . . .
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Krystal Biotech announced that inhaled KB707 gene therapy for the treatment of metastasized tumors in the lung that are not successfully treated with standard therapy has been granted Fast Track designation by the FDA. The… Read more . . .
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AstraZeneca has announced the US launch of its Airsupra albuterol / budesonide MDI, which was approved by the FDA in January 2023 for the treatment of asthma in people aged 18 and over. Airsupra (PT027)… Read more . . .
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PureIMS announced that a Phase 1 PK study that compared the company’s Levodopa Cyclops to Inbrija levodopa DPI, demonstrated “high comparability with a marketed inhaled levodopa product,” with faster initial absorption and no safety or… Read more . . .
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Pulmatrix announced that it will halt a Phase 2b trial of PUR1900 dry powder itraconazole (Pulmazole) in patients with allergic bronchopulmonary aspergillosis (ABPA) that was initiated in February 2023. The company says that the move is part… Read more . . .
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Liquidia Corporation announced that it has initiated the ASCENT open-label safety and tolerability study of Yutrepia (LIQ861) treprostinil DPI in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD). The 52-week study is expected… Read more . . .
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Theravance Biopharma announced that the Phase 4 PIFR-2 study of nebulized Yupelri revefenacin inhalation solution versus Spiriva HandiHaler tiotropium DPI in patients with severe to very severe COPD failed to demonstrate any significant difference in… Read more . . .
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