Regulatory
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Aculys Pharma says that it plans to move ahead with submission of a marketing application to Japanese authorities based on interim data showing that a Japanese Phase 3 clinical study of NRL-1 diazepam nasal spray… Read more . . .
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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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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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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 . . .
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Orexo announced that it has resubmitted an NDA for OX124 naloxone nasal powder for the reversal of opioid overdose. In February 2023, the company announced that it had submitted an NDA for OX124 and then… Read more . . .
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The FDA issued a document on September 8, 2023 titled “Application of Human Factors Engineering Principles for Combination Products: Questions and Answers,” which is the final version of a draft guidance titled “Human Factors Studies… Read more . . .
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NurExone Biologic announced that the company has received feedback from the FDA following a pre-IND meeting regarding NurExone’s ExoPTEN intranasal exosome therapy and now plans to submit an IND by the end of this year… Read more . . .
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According to Verona Pharma, the FDA has accepted the company’s NDA for its nebulized ensifentrine (RPL554) for the treatment of COPD with a PDUFA target date of June 26, 2024. The company submitted the NDA… Read more . . .
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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