December 2016
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The FDA is touting its June 1, 2021 approval of Sandoz’s ANDA for an albuterol sulfate MDI for the treatment of asthma, saying, “The FDA recognizes the increased demand for certain products during the COVID-19… Read more . . .
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Lupin has announced the US launch of an authorized generic version of Sunovion’s Brovana arformoterol tartrate inhalation solution for the treatment of COPD. The FDA tentatively approved the company’s ANDA for the inhalation solution in… Read more . . .
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Evoke Pharma said that the United States Patent and Trademark Office (USPTO) has issued US patent No. 11,020,361 (“Nasal Formulations of Metoclopramide”) covering methods of use for Gimoti metoclopramide nasal spray for the treatment of gastroparesis… Read more . . .
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According to Liquidia, the FDA has accepted the company’s resubmitted NDA for LIQ861 treprostinil DPI for the treatment of pulmonary arterial hypertension and has set a PDUFA goal date of November 7, 2021. Liquidia initially… Read more . . .
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Aerosol testing specialist Proveris Scientific has named Maria L. Smith as Director, Application and Business Development for Proveris Laboratories. Smith has extensive experience in OINDP spray characterization, first at DPT Laboratories and then at Renaissance Lakewood.… Read more . . .
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Inhaler monitoring company Adherium has submitted a 510(k) application for a new Hailie sensor designed to work with the Symbicort MDI the company announced. The company recently rejected a takeover bid from another Australian asthma… Read more . . .
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Noveome Biotherapeutics has signed a commercial license agreement for the use of SipNose’s intranasal Cribriform Targeted Device (CT6) for delivery of its ST266 secretome for the treatment of ophthalmological and CNS conditions the companies said.… Read more . . .
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According to Lannett, the FDA has set a GDUFA goal date of January 31, 2022 for completion of its review of the ANDA for Respirent’s generic version of Advair Diskus fluticasone propionate / salmeterol DPI… Read more . . .
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AIM ImmunoTech said that it has extended a 2020 agreement with Shenzhen Smoore Technology related to development of an inhaled version of its Ampligen rintatolimod for the treatment of COVID-19. The agreement with Smoore is… Read more . . .
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The EMA’s COVID-19 task force has said “that there is currently insufficient evidence that inhaled corticosteroids are beneficial for people with COVID-19.” In addition, the task force said that “it could not exclude the possibility… Read more . . .
Featured event:
5th Annual Inhaled & Nasal Biologics | DNA Forum
5th Annual Inhaled & Nasal Biologics | DNA Forum
24th-25th September 2026, Cambridge, UK
Join us for a ground-breaking and insightful forum: Two days of cutting-edge talks and networking opportunities in this complex area of drug and vaccine development.
With renowned industry leaders who will share their insights and real-world case studies, our speakers will explore innovative formulation and delivery technologies and the rationale behind overcoming development challenges. Don’t miss out on this opportunity to learn more about key topics shaping the future of inhaled therapeutics.
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Upcoming Events
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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
November 10-November 11: Rescon Europe 2026, Porto, Portugal
December 9-December 11: DDL 2026, Edinburgh, Scotland