Regulatory
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Irish biopharm company GH Research said that it has completed inhalation toxicology studies of GH001 inhaled mebufotenin (5-MeO-DMT) necessary to address the FDA’s 2023 clinical hold on an IND that the company had submitted for a… Read more . . .
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ARS Pharmaceuticals announced that it has submitted marketing applications for neffy epinephrine (adrenalin) nasal spray in Canada and in the UK. The nasal spray has been approved in the US and in Europe (as EURneffy) for the… Read more . . .
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Endo USA has recalled all unexpired lots of Adrenalin Chloride Solution epinephrine nasal solution, which is meant for topical application, due to FDA concerns about the potential for confusion of the product with the company’s… Read more . . .
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The US Court of Appeals for the Federal Circuit has upheld a ruling from district court that requires Teva to remove patents covering inhaler device and dose counter IP from the FDA’s Orange Book. In… Read more . . .
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Savara announced that it has initiated a rolling biologics license application submission for its Molbreevi molgramostim inhalation solution for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP). The company said that it will request priority review… Read more . . .
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According to PureIMS, both the EMA and FDA have recently granted orphan drug designation to the company’s Colistin Cyclops dry powder inhaler for the treatment of P. aeruginosa infections in cystic fibrosis patients. Colistin Cyclops is… Read more . . .
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ARS Pharmaceuticals has announced that its partners in China, Japan, and Australia have all submitted marketing applications for approval of neffy epinephrine nasal spray for the treatment of serious allergic reactions in their respective countries. ARS is… Read more . . .
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According to MannKind Corporation, the Indian Central Drugs Standard Control Organization (CDSCO) has approved a marketing application submitted by Cipla for Afrezza inhaled dry powder insulin for the treatment of diabetes in adults. Cipla acquired the… Read more . . .
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According to Iliad Biotechnologies, the UK Medicines & Healthcare Products Regulatory Agency (MHRA) has granted Innovation Passport designation to Iliad’s BPZE1 intranasal pertussis vaccine. BPZE1, which is in Phase 2 development, has previously received Fast Track designation… Read more . . .
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According to Satsuma Pharmaceuticals and its parent company Shin Nippon Biomedical Laboratories, the FDA has accepted the company’s resubmitted NDA for STS101 dihydroergotamine nasal powder for the treatment of migraine and has set a PDUFA… Read more . . .
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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