News
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GH Research announced that the FDA has placed a clinical hold on an IND that the company submitted for GH001 inhaled mebufotenin (5-MeO-DMT) for the treatment of treatment-resistant depression, citing “Insufficient information to assess risks… Read more . . .
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Avalyn Pharma announced that an oversubscribed Series C financing brought in $175 million that the company will use for continued development of AP01 inhaled pirfenidone and AP02 inhaled nintedanib for the treatment of pulmonary fibrosis.… Read more . . .
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The Cystic Fibrosis Foundation announced that it has agreed to provide an additional $9 million in funding for development of Arcturus Therapeutics’ ARCT-032 inhaled mRNA therapy for the treatment of CF. The CF Foundation said… Read more . . .
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According to Defender Pharmaceuticals, the FDA has accepted the company’s NDA for DPI-386 scopolamine nasal gel for the treatment of motion sickness for priority review, with a PDUFA goal date of January 26, 2024. Defender… Read more . . .
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Liquidia Corporation said that the FDA has accepted its sNDA to add pulmonary hypertension associated with interstitial lung disease (PH-ILD) as an indication for Yutrepia treprostinil inhalation powder without requiring any additional studies and has set… Read more . . .
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Krystal Biotech said that the FDA has cleared an IND for KB408 nebulized gene therapy for the treatment of alpha-1 antitrypsin deficiency, and the company said that it plans to initiate a Phase 1 trial… Read more . . .
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Seelos Therapeutics asserts that the second part of its Phase 2 trial of SLS-002 intranasal racemic ketamine for the treatment of acute suicidal ideation and behavior in major depressive disorder would have met its primary… Read more . . .
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The International Society for Aerosols in Medicine (ISAM) welcomed more than 260 attendees to its 2023 biannual congress August 26-30 in Saarbrücken, Germany, reports organizing committee member Claus-Michael Lehr of the Helmholtz Institute for Pharmaceutical… Read more . . .
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ReCode Therapeutics announced that it has raised $50 million as an extension to a Series B financing, with funds going toward clinical development of its inhaled mRNA therapies for the treatment of primary ciliary dyskinesia… Read more . . .
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According to ARS Pharmaceuticals, the FDA has issued a complete response letter to the company’s NDA for Neffy epinephrine nasal spray for the treatment of allergic reactions, including anaphylaxis, and the agency has requested the completion of a… Read more . . .
Upcoming Events
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September 15-September 18: DDL New Researcher Network Summer Event, London, UK
September 16-September 17: IPAC-RS 2026 Nasal Innovation Forum, Jersey City, NJ, USA
September 24-September 25: Inhaled & Nasal Biologics | DNA Forum, Cambridge, UK
October 14-October 15: Advancing Bioequivalence Frameworks for Inhalation and Nasal Drug Products: Optimizing In Vitro, In Vivo, and In Silico Methods, Rockville, MD, USA
October 19-October 20: MVIC Autumn Training 2026, Lund, Sweden