Regulatory
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VistaGen Therapeutics has announced that it is proposing a Phase 2a study of its PH94B aloradine nasal spray for the treatment of patients with adjustment disorder with anxiety caused by the COVID-19 pandemic, subject to approval… Read more . . .
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Verona Pharma says that the FDA’s comments in response to the data from a Phase 2 study of the company’s RPL554 nebulized ensifentrine for the treatment of COPD support moving ahead with a Phase 3… Read more . . .
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Pulmotect said that it plans to initiate two Phase 2 trials of its PUL-042 immunostimulant inhalation solution for the prevention and treatment of COVID-19 within a week after getting the go-ahead from the FDA. In… Read more . . .
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The FDA has approved an IND for a Phase 2 study of GeneOne Life Science’s GLS-1200 nasal spray for the prevention of COVID-19, the company said. According to GeneOne, GLS-1200 stimulates nasal production of nitric… Read more . . .
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At its April 2020 meeting, the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorization for Enerzair Breezhaler (QVM149) indacaterol / glycopyrronium / mometasone for the treatment of uncontrolled asthma as… Read more . . .
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According to Lupin, the FDA has tentatively approved the company’s arformoterol tartrate inhalation solution, a generic version of Sunovion’s Brovana, for the treatment of COPD. Sunovion’s final patent covering Brovana expires in November 2021. Brovana… Read more . . .
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According to Zambon, the FDA has granted Fast Track designation to the company’s liposomal cyclosporine A for inhalation (L‑CsA‑i), which is in Phase 3 development for the treatment of bronchiolitis obliterans syndrome (BOS). Zambon acquired… Read more . . .
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The FDA has approved an Aurobindo ANDA for generic albuterol (salbutamol) sulfate inhalation solution and, while the agency did not issue a press release, the news was included in the FDA’s COVID-19 “Daily Roundup” and… Read more . . .
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According to Beyond Air, the company has received permission from the FDA to initiate a clinical study of its LungFit inhaled nitric oxide system for the treatment of COVID-19 patients. The announcement comes almost a month… Read more . . .
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German medical device company B. Braun Medical announced that the FDA has issued Emergency Use Authorization (EUA) of several of the company’s infusion pumps for “tracheal delivery of continuous nebulized medications into a nebulizer to… Read more . . .
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October 21-October 22: MVIC Symposium, Lund, Sweden
October 28-October 30: Deutches Aerosol Therapie Symposium (DATS), Marburg, Germany
November 10-November 11: Rescon Europe 2026, Porto, Portugal
December 9-December 11: DDL 2026, Edinburgh, Scotland