Regulatory
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According to SpliSense, the FDA has granted Fast Track designation to the company’s SPL84 inhaled antisense oligonucleotide for the treatment of cystic fibrosis. SPL84 had already received Orphan Drug designation from both the FDA and… Read more . . .
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Amphastar Pharmaceuticals announced that the FDA has approved the company’s ANDA for a generic version of Teva’s ProAir HFA albuterol MDI for the treatment of asthma and said that it plans to launch the inhaler in… Read more . . .
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EVŌQ Bio said that it had positive feedback from the FDA following a pre-IND meeting about EVQ-218 inhaled non-ionic silver nanoparticle, which the company is developing for the treatment of pulmonary bacterial infections in cystic… Read more . . .
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ENA Respiratory announced that the US Patent and Trademark Office (USPTO) has issued a Notice of Allowance for a patent application titled “Novel molecules” (US 18/112091), which covers the company’s INNA-051 intranasal TLR2/6 agonist. According… Read more . . .
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MannKind Corporation announced that its MNKD-101 clofazimine inhalation suspension for the treatment of nontuberculous mycobacterial (NTM) lung infections has been granted Fast Track designation by the FDA. MNKD-101 had already received orphan drug and qualified infectious… Read more . . .
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ARS Pharmaceuticals announced has submitted its Day 180 response regarding the company’s MAA for Neffy epinephrine nasal spray to the EMA’s Committee for Medicinal Products for Human Use (CHMP) and expects an opinion on the… Read more . . .
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MannKind Corporation announced that the FDA has cleared the company’s IND for the ICoN-1 Phase 3 study of MNKD-101 clofazimine inhalation suspension in patients with nontuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium complex (MAC). The… Read more . . .
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According to ENA Respiratory, the FDA has cleared the company’s IND for a Phase 1b study of a dry powder formulation of INNA-051, a TLR2/6 agonist, which the company has been developing as a pan-viral… Read more . . .
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Amneal Pharmaceuticals announced that it has launched a generic over-the-counter naloxone nasal spray for the reversal of opioid overdose after its ANDA for the product was approved by the FDA. Amneal had announced the agency’s… Read more . . .
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According to inhaler monitor company Adherium, the FDA has cleared the Hailie Smartinhaler sensor for use with the Airsupra albuterol / budesonide MDI and with the Breztri Aerosphere budesonide / glycopyrronium / formoterol fumarate MDI,… 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