Regulatory
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Cipla said that it has received final approval for an ANDA for its generic version of Bausch’s Migranal dihydroergotamine (DHE) mesylate nasal spray for the treatment of migraine. According to Cipla, this is the company’s… Read more . . .
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The Chinese National Medical Products Administration (NMPA) has approved AstraZeneca’s Bevespi Aerosphere glycopyrronium/formoterol fumarate MDI for the treatment of COPD, the company said. AstraZeneca’s Breztri Aerosphere budesonide/glycopyrronium/formoterol fumarate MDI was approved for the treatment of COPD by… Read more . . .
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Teva Canada said that it has imported a 4-week supply of Salamol salbutamol (albuterol) sulfate MDIs through Teva UK under an interim order by the Minister of Health in response to shortages of the inhalers in Canada caused… Read more . . .
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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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