Regulatory
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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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NurExone Biologic announced that the EMA has granted orphan medicinal product designation to NurExone’s ExoPTEN intranasal exosome therapy, which the company is developing for the treatment of spinal cord injury. In 2023, the FDA granted orphan drug… Read more . . .
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AlveoGene’s AVG-002 inhaled gene therapy gets rare pediatric disease designation for SP-B deficiency
UK-based start-up AlveoGene announced that its AVG-002 nebulized gene therapy for neonatal surfactant protein B (SP-B) deficiency has received a rare pediatric disease designation from the FDA. The company says that it will advance AVG-002… Read more . . .
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Satsuma Pharmaceuticals announced that it has resubmitted its NDA for STS101 intranasal dry powder dihydroergotamine for the acute treatment of migraine with or without aura. The company initially submitted the NDA in March 2023 even though the… Read more . . .
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According to Qnovia (formerly Respira Technologies), the FDA has cleared an IND submitted by the company for a trial of its QN-01 RespiRx nicotine inhaler, which the company is developing for smoking cessation. The company says… Read more . . .
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The FDA and AstraZeneca are both touting the agency’s approval of FluMist intranasal influenza vaccine for caregiver administration to children aged 2-17 and for self-administration by adults up to age 49. The agency agreed to… Read more . . .
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The FDA has advised California-based Green Pharmaceuticals to recall its SnoreStop nasal spray due to “significant microbial contamination in SnoreStop Nasal Spray lot number 2460” detected during an inspection in April 2024 and is warning… Read more . . .
Upcoming Events
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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