Regulatory
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Trimel Pharmaceuticals has submitted a New Drug Application (NDA) to the FDA regarding its CompleoTRT bioadhesive intranasal gel testosterone for the treatment of testosterone deficiency in men. According to the company, the intranasal gel is… Read more . . .
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GlaxoSmithKline says that it has submitted a Marketing Authorisation Application (MAA) to the EMA for umeclidinium bromide (UMEC) monotherapy to be delivered using the Ellipta DPI for the treatment of COPD. UMEC is a long-acting… Read more . . .
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GlaxoSmithKline and Theravance have submitted an application for the Anoro Ellipta umeclidinium bromide /vilanterol (UMEC/VI) DPI for the treatment of COPD to the Japanese Ministry of Health, Labour and Welfare (MHLW), the companies said. The… Read more . . .
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The FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) has voted to recommend approval of of GSK and Theravance’s Breo Ellipta fluticasone furoate/vilanterol (FF/VI) DPI for the treatment of COPD. The PADAC meeting had been rescheduled from… Read more . . .
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Allergan, which recently acquired MAP Pharmaceuticals, has announced that it has received a Complete Response Letter (CRL) from the FDA in regard to its NDA for Levadex inhaled dihydroergotamine for the treatment of migraines. The… Read more . . .
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According to Discovery Laboratories its Aerosurf aerosolized surfactant development program “currently remains on track for the Phase 2 clinical program in the fourth quarter of 2013” and is unaffected by the FDA’s recent questions about… Read more . . .
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The FDA draft guidance on albuterol sulfate MDIs published April 8, 2013 includes recommendations for a total of 7 studies, including 5 in vitro studies, 1 PK study, and 1 PD study to establish bioequivalence.… Read more . . .
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According to Insmed Incorporated, the US FDA has granted orphan drug designation to its Arikace liposomal amikacin for inhalation for the treatment of non-tuberculous mycobacteria (NTM) infections. Insmed is also developing Arikace for the treatment… Read more . . .
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The UK’s National Institute for Health and Care Excellence (NICE) has issued a final guidance recommending Novartis’s Tobi Podhaler tobramycin DPI and Forest Lab’s Colobreathe colistimethate sodium DPI for the treatment of P. aeruginosa lung… Read more . . .
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According to the EMA, its Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion regarding the Labazenit budesonide/salmeterol dry powder inhaler. Belgian pharmaceutical company Laboratoires SMB applied to market the product, which… Read more . . .
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October 14-October 15: Advancing Bioequivalence Frameworks for Inhalation and Nasal Drug Products: Optimizing In Vitro, In Vivo, and In Silico Methods, Rockville, MD, USA
October 19-October 20: MVIC Autumn Training 2026, Lund, Sweden
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