Regulatory
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AstraZeneca has announced that the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) has voted to recommend the use of FluMist Quadrivalent intranasal live Influenza vaccine for the 2018-19 flu… Read more . . .
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The US Patent and Trademark Office has issued US Patent Number 9,895,385, titled “Methods for treating pulmonary non-tuberculous mycobacterial infections” to Insmed Incorporated, the company said. According to Insmed, the patent is the 9th for… Read more . . .
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The FDA has accepted Acorda Therapeutics’ revised NDA for Inbrija inhaled levodopa for the treatment of symptoms associated with OFF periods in Parkinson’s disease in patients taking carbidopa/levodopa, the company said. The PDUFA target date… Read more . . .
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GlaxoSmithKline and Innoviva have announced the submission of a type II variation application seeking expanded use for the Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) DPI for the treatment of COPD. Trelegy Ellipta was granted marketing authorization… Read more . . .
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According to Savara, the FDA has approved an IND the company submitted for Molgradex, an inhaled molgramostim (recombinant human GM-CSF) formulation for the treatment of autoimmune pulmonary alveolar proteinosis (PAP), which the company filed in… Read more . . .
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The FDA has granted orphan drug designation to Dauntless Pharmaceuticals’ DP1038 intranasal octreotide acetate for the treatment of acromegaly, the company said. Dauntless announced positive Phase 1 results for DP1038 in May 2015. Dauntless Pharmaceuticals… Read more . . .
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Theravance Biopharma and Mylan have announced that the NDA for revefenacin (TD-4208) inhalation solution for the treatment of COPD the companies submitted in November 2017 has been accepted for review by the FDA, with a… Read more . . .
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Aradigm Corporation has received a complete response letter from the FDA in response to its NDA for Linhaliq dual release inhaled ciprofloxacinfor the treatment of P. aeruginosa infections in non-cystic fibrosis bronchiectasis (NCFBE) patients, the… Read more . . .
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According to GlaxoSmithKline and Innoviva, the EMA’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion regarding approval of the Relvar Ellipta fluticasone furoate/vilanterol DPI for the treatment of asthma that… Read more . . .
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The Icelandic Medicines Agency has approved an MAA filed by Medical Developments International (MVP) to allow marketing of Penthrox inhaled methoxyflurane for the treatment of pain due to traumatic injury. The company said that Penthrox… Read more . . .
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