Regulatory
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Impax Specialty Pharma has received approval from the FDA to market Zomig zolmitriptan nasal spray for the treatment of migraine in patients 12-17 years of age, the company says. Impax acquired the US rights to… Read more . . .
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According to United Therapeutics, the company has received notice that Watson Laboratories, a subsidiary of Allergan, has submitted an Abbreviated New Drug Application (ANDA) for a generic version of United Therapeutics’ Tyvaso treprostinil inhalation solution.… Read more . . .
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Adapt Pharma has initiated a rolling NDA submission for intranasal naloxone for the treatment of opioid overdose, the company said. Adapt licensed the intranasal naloxone formulation from Lightlake Therapeutics in December 2014 and received Fast… Read more . . .
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According to Boehringer Ingelheim, the FDA has approved its tiotropium bromide/olodaterol soft mist inhaler for the treatment of COPD. The company filed an NDA for the product, which will be marketed as Stiolto Respimat Inhalation… Read more . . .
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Advanced Inhalation Therapies (AIT) has announced that its AIT-CF high dose inhaled formulation of nitric oxide (NO) for the treatment of cystic fibrosis has been granted orphan medical product designation by the European Commission. In… Read more . . .
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The FDA has approved GSK’s supplemental NDA for the Breo Ellipta fluticasone furoate/vilanterol DPI, allowing GSK to market the inhaler for the treatment of asthma in patients aged 18 years and older. Breo Ellipta was… Read more . . .
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Aptar Pharma has announced that the Chinese State Food and Drug Administration (SFDA) has issued the company an import license for its preservative-free multi-dose opthalmic and nasal devices in accordance with regulations that require “Examination… Read more . . .
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PARI Pharma has received European marketing authorization for its Vantobra 170 mg tobramycin/1.7 ml inhalation solution for the treatment of P. aeruginosa infections in cystic fibrosis patients aged 6 and older, the company said. Vantobra… Read more . . .
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Kyorin Pharmaceutical has announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved its marketing application for the Eklira Genuair aclidinium bromide DPI for the treatment of COPD in 30 and 60… Read more . . .
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The FDA has now approved Teva’s ProAir RespiClick albuterol DPI for the treatment of asthma in patients aged 12 and older, the company said. Teva had announced tentative approval of the product, which was previously… 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