Regulatory
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According to Aradigm Corporation, the FDA has accepted its NDA for Linhaliq dual release inhaled ciprofloxacin for the treatment of chronic P. aeruginosa infections in non-cystic fibrosis bronchiectasis (NCFBE) patients for priority review. The agency… Read more . . .
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GlaxoSmithKline announced that its NDA for Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol for the treatment of COPD has been approved by the FDA. GSK said that Trelegy Ellipta should be available to patients in the US “shortly.”… Read more . . .
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The FDA has approved Optinose’s Xhance fluticasone propionate nasal spray (formerly OPN-375) for the treatment of nasal polyps, the company said. The product, which is based on the company’s exhalation delivery technology, should be available… Read more . . .
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The EMA Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Mundipharma’s MAA for Nyxoid naloxone nasal spray for the reversal of opioid overdose. Currently, no intranasal naloxone formulations are approved for… Read more . . .
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The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion regarding GSK’s MAA for its triple combination fluticasone furoate/umeclidinium/vilanterol DPI for the treatment of COPD in patients… Read more . . .
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The FDA has approved a supplemental NDA for AstraZeneca’s Symbicort budesonide/formoterol fumarate MDI extending its use to include the reduction of COPD exacerbations. The sNDA, which was approved on September 11, 2017, included supporting data… Read more . . .
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Summit Biosciences has announced that it can now produce prescription nasal sprays for the the European market after receiving EU GMP certification from the Medicines and Healthcare Products Regulatory Agency (MHRA) for its manufacturing facilities… Read more . . .
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Now that the Phase 3 CONVERT study has met its primary endpoint of culture conversion with statistical and clinical significance by Month 6, Insmed said, the company plans to seek priority review and accelerated approval… Read more . . .
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Acorda Therapeutics has received a refusal to file letter from the FDA in response to its NDA for Inbrija (CVT-301) inhaled levodopa for the treatment of OFF periods in Parkinson’s disease patients, the company said.… Read more . . .
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Altimmune has submitted an investigational new drug application to FDA for its NasoVAX intranasal flu vaccine and is planning a Phase 2 study of the product, the company said. The safety and immunogenicity study is… Read more . . .
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