Regulatory
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The FDA announced that it has approved an Rx to OTC switch for Amphastar Pharmaceutical’s Rextovy 4 mg naloxone nasal spray. Amphastar’s naloxone nasal spray was initially approved for the treatment of opioid overdose by… Read more . . .
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According ALK, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved use of a 1 mg dose of EURneffy adrenaline nasal spray for the treatment of anaphylaxis in children aged 4 and older who… Read more . . .
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MannKind Corporation announced that the FDA has approved the company’s sBLA for use of Afrezza inhaled dry powder insulin for the treatment of Type 1 and Type 2 diabetes in children aged 6 and older. Afrezza was… Read more . . .
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According to Lupin, the FDA has tentatively approved the company’s ANDA for revefenacin inhalation solution, a generic of Mylan’s Yupelri inhalation solution. Yupelri was approved by the FDA for the treatment of COPD in 2018.… Read more . . .
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According to Chance Pharmaceuticals, China’s National Medical Products Administration has accepted the company’s NDA for CXG87 budesonide / formoterol DPI for the treatment of asthma. The announcement emphasizes that the formulation is Chance’s own “improved… Read more . . .
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Insilico Medicine, which has facilities in the US and China, said that an IND for a Phase 1 PK trial of rentosertib (ISM001-055) inhalation solution has been cleared by the CDE. The company said that… Read more . . .
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AstraZeneca announced that the FDA has approved the company’s Breztri Aerosphere budesonide / glycopyrrolate / formoterol MDI for the treatment of asthma in patients aged 12 and older. The agency originally approved Breztri for the treatment of… Read more . . .
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Cipla has received FDA approval of its ANDA for a generic version of Ventolin HFA albuterol MDI for the treatment of asthma, the company announced. GSK’s NDA Ventolin HFA was approved by the agency in… Read more . . .
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Vistagen announced that it has received a “study may proceed” letter from the FDA in response to the company’s IND for a Phase 2 trial of refisolone nasal spray for the treatment of hot flashes caused… Read more . . .
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Savara has announced that the FDA is giving itself extra time to review the company’s BLA for molgramostim inhalation solution for the treatment of autoimmune pulmonary alveolar proteinosis, setting November 22, 2026 as the new… Read more . . .
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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
October 21-October 22: MVIC Symposium, Lund, Sweden
November 10-November 11: Rescon Europe 2026, Porto, Portugal
December 9-December 11: DDL 2026, Edinburgh, Scotland