Regulatory
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A US District Court has ordered Wockhardt subsidiary Morton Grove Pharmaceuticals “to stop manufacturing and distributing drugs alleged to be adulterated.” The Morton Grove facility manufactured fluticasone propionate nasal sprays in addition to other products.… Read more . . .
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According to Lupin, the FDA has approved the company’s ANDA for a generic version of Mylan’s Perforomist formoterol fumarate inhalation solution. Teva launched a generic equivalent in the US in June 2021 after expiration of… Read more . . .
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According to Nuance Pharma, the Chinese Center for Drug Evaluation has approved the company’s IND, allowing for a Phase 3 trial of nebulized ensifentrine, a PDE3/PDE4 inhibitor for the treatment of COPD, in China. The… Read more . . .
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Harm Reduction Therapeutics announced that it has signed a commercial supply agreement for its RiVive (HRT001) intranasal naloxone after the FDA granted Fast Track designation to the nasal spray, which is in development as a… Read more . . .
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Just over a week after receiving 510(k) clearance for a Hailie inhaler sensor for use with Ellipta DPIs, Adherium said that it filed a 510(k) submission to the FDA for a new Hailie sensor to… Read more . . .
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Renovion announced that the company has gotten the go-ahead from the FDA to initiate a Phase 3 clinical trial of its ARINA-1 nebulized glutathione / bicarbonate / ascorbic acid for the prevention of bronchiolitis obliterans… Read more . . .
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Hailie inhaler monitoring system maker Adherium announced that the FDA has cleared the company’s new version of the Hailie sensor for use with Ellipta dry powder inhalers. Adherium submitted the 510(k) application to the FDA… Read more . . .
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According to Liquidia, the US Patent Trial and Appeal Board (PTAB) has found that none of the claims included in US Patent No. 10,716,793, covering Tyvaso inhaled treprostinil, are valid. The company said that the PTAB ruling would have… Read more . . .
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According to Beyond Air, the FDA has approved the company’s LungFit PH inhaled nitric oxide (iNO) generation and delivery system for the treatment of babies with persistent pulmonary hypertension of the newborn (PPHN). The approval is… Read more . . .
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Altamira Therapeutics (formerly Auris Medical) announced that the company has received 510(k) clearance to sell its Bentrio Allergy Blocker nasal spray over the counter for the treatment of allergic rhinitis in the US. The company… 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