Regulatory
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The Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the Anoro Ellipta umeclidinium/vilanterol DPI for the treatment of COPD, GlaxoSmithKline and Theravance have announced. In April 2013, the companies announced that they had… Read more . . .
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Boehringer Ingelheim has announced that it has applied for approval to market its tiotropium/olodaterol Respimat soft mist inhaler for the treatment of COPD in the EU. Both of the individual drugs in the new combination… Read more . . .
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GSK and Theravance have submitted a supplemental New Drug Application (sNDA) to the FDA for the Breo Ellipta fluticasone furoate/vilanterol DPI for the treatment of asthma in patients 12 years old and older, the companies… Read more . . .
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According to Allergan, the FDA has issued another Complete Response Letter (CRL) in response to Allergan’s NDA for Semprana inhaled dihydroergotamine (formerly Levadex) for the treatment of acute migraine. Allergan acquired the product when it… Read more . . .
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The US FDA has announced the approval of MannKind Corporation’s Afrezza inhaled insulin for the treatment of diabetes. The PDUFA date for Afrezza had been set for July 15, 2014 after the FDA’s Endocrinologic and… Read more . . .
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The US Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) has recommended that children aged 2-8 should get a nasal spray flu vaccine if available instead of an injection. The… Read more . . .
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Strativa Pharmaceuticals has announced that it has received FDA approval for its disposable single-dose device version of Nascobal cyanocobalamin nasal spray for the treatment of pernicious anemia and other vitamin B12 deficiencies. The new product… Read more . . .
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According to Smartinhaler manufacturer Nexus6, the FDA has granted 510(k) marketing clearance for a new version of the inhaler monitoring system called SmartTouch. The system includes a touch screen on the monitoring device and is… Read more . . .
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According to Trimel Pharmaceuticals, the FDA has approved its Natesto nasal testosterone for men with low levels of endogenous testosterone. Trimel submitted an NDA for the product, then called CompleoTRT, in April 2013. Trimel President… Read more . . .
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The FDA has approved Teva’s QVAR beclomethasone HFA metered dose inhaler with a dose counter for the treatment of asthma, and the company plans to launch the product later in 2014, Teva said. Teva Global… Read more . . .
Upcoming Events
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September 15-September 18: DDL New Researcher Network Summer Event, London, UK
September 16-September 17: IPAC-RS 2026 Nasal Innovation Forum, Jersey City, NJ, USA
September 24-September 25: Inhaled & Nasal Biologics | DNA Forum, Cambridge, UK
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