Medical
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The PAP Foundation, a US organization that advocates for pulmonary alveolar proteinosis (PAP) patients, says that it supports FDA approval of Savara’s Molgradex inhaled recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF). The group said that it… Read more . . .
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Milestone Pharmaceuticals has reported that the Phase 3 NODE-301 trial of its etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT) has missed its primary endpoint of time to conversion of SVT to… Read more . . .
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Windtree Therapeutics has announced that it plans to study its KL4 surfactant for the treatment of acute respiratory distress syndrome (ARDS) in patients suffering from COVID-19. Windtree’s Aerosurf — KL4 delivered via the company’s proprietary… Read more . . .
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Ampio Pharmaceuticals announced that it plans to submit an expanded access protocol to the FDA to study the effects of a nebulized formulation of its Ampion anti-inflammatory biologic in patients with moderate to severe acute… Read more . . .
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Biohaven Pharmaceutical has announced that it met with the FDA following completion of Phase 2 clinical trials of its intranasal vazegepant (BHV-3500) for the treatment of migraine and is ready to advance the 10 mg… Read more . . .
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The UK Medicines and Healthcare products Regulatory Agency (MHRA) and Health Research Authority (HRA) have expedited approvals for a Phase 2 trial of Synairgen’s SNG001 nebulized interferon-beta-1a for the treatment of COVID-19, the company said. According… Read more . . .
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Beyond Air said that it has submitted an investigational device exemption (IDE) to the FDA seeking to use its cylinder-free LungFit BRO inhaled nitric oxide (iNO) delivery system for the treatment of COVID-19. Beyond Air has been developing… Read more . . .
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Engage Therapeutics said that the Phase 2b StATES (Staccato Alprazolam Terminates Epileptic Seizures) trial of Staccato inhaled alprazolam in epilepsy patients has met its primary endpoint, terminating seizure activity within two minutes of dosing with no recurrence… Read more . . .
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Otitopic announced that it has held discussions with the FDA regarding a pivotal PK/PD study of its Asprihale aspirin dry powder inhaler and now expects to initiate the study in the fourth quarter of 2020.… Read more . . .
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United Therapeutics has announced that the Phase 3 INCREASE study of Tyvaso treprostinil inhalation solution for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD) met its primary endpoint, demonstrating statistically significant improvement in six-minute… Read more . . .
Upcoming Events
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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