Regulatory
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GlaxoSmithKline has submitted an NDA for its umeclidinium (UMEC) Ellipta DPI for the treatment of COPD to the Japanese Ministry of Health, Labour and Welfare, the company announced. The product was approved under the name… Read more . . .
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Aradigm has announced that the FDA has designated its Pulmaquin inhaled ciprofloxacin for the treatment of P. aeruginosa infections in non-cystic fibrosis bronchiectasis patients as a Qualified Infectious Disease Product (QIDP). QIDP status makes the… Read more . . .
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As part of an interim management statement, Skyepharma has said that the launch of its Flutiform fluticasone/formoterol MDI in Spain could take place by the end of 2014, triggering a milestone payment of €2.0 million.… Read more . . .
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Apotex says that it launched a generic budesonide nasal spray in the US on May 13, 2014 following the previous day’s approval of the product by the FDA. The new product, with a strength of… Read more . . .
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Teva has announced the FDA’s acceptance of its supplemental NDA for a low-dose formulation of QNASL beclomethasone dipropionate HFA nasal spray for the treatment of allergic rhinitis in children aged 4-11. The FDA approved QNASL… Read more . . .
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Perrigo has announced that it has begun shipping its generic version of Astepro azelastine nasal spray after the ANDA it submitted in partnership with Impax Laboratories received final approval from the FDA. In January 2012,… Read more . . .
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GlaxoSmithKline and Theravance have announced that they have received marketing authorization for the Anoro Ellipta umeclidinium/vilanterol DPI for the treatment of COPD in Europe. The EMA’s Committee for Medicinal Products for Human Use (CHMP) issues… Read more . . .
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Propeller Health (formerly known as Asthmapolis) has announced that the latest version of its inhaler tracking system has received 510(k) clearance from the FDA. The system includes a sensor that snaps onto an MDI and… Read more . . .
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The FDA has issued a Complete Response Letter (CRL) for Acorda Therapeutics’ Plumiaz diazepam nasal spray for the treatment of cluster seizures in epilepsy patients, the company has announced. Acorda submitted a 505(b)(2) application for… Read more . . .
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Less than a week after the approval of GSK’s Incruse Ellipta umeclidinium DPI in Europe, the company has announced that the FDA has approved the product for the treatment of COPD and it expects to… 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