Regulatory
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According to Emergent BioSolutions, the FDA has accepted the company’s supplemental NDA for over-the-counter (OTC) sales of Narcan naloxone nasal spray for the reversal of opioid overdose and has set a PDUFA goal date of March… Read more . . .
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The FDA has awarded Fast Track designation to Vistagen’s PH10 pherin nasal spray for the treatment of major depressive disorder, the company said. Vistagen recently announced its plans for a Phase 1 trial of a re-formulated version… Read more . . .
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The FDA has approved Aucta Pharmaceuticals’ ANDA for its formoterol fumarate inhalation solution, a generic version of Mylan’s Perforomist. Aucta’s is the 4th Perforomist equivalent approved since the expiration of Mylan’s final patent covering the… Read more . . .
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Adherium announced that the FDA has granted 510(k) clearance for use of Adherium’s next-generation Hailie inhaler sensor with GSK’s Ventolin, Advair, and Flovent MDIs. The company had announced submission of the 510(k) application in August… Read more . . .
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According to Opiant Pharmaceuticals, the submission of its NDA for OPNT003 nalmefene nasal spray for the treatment of opioid overdose has been completed, and the FDA’s decision on acceptance of the application is expected in… Read more . . .
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The FDA has issued a notice in the Federal Register titled, “Safety and Effectiveness of Certain Naloxone Hydrochloride Drug Products for Nonprescription Use.” The agency says that its preliminary opinion is that autoinjectors with doses up… Read more . . .
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According to Viatris, the US District Court for the Northern District of West Virginia has determined that US Patent No. 10,166,247, which covers AstraZeneca’s Symbicort budesonide / formoterol MDI, is invalid. In March 2021, the same court upheld… Read more . . .
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The FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted 16 to 1 that the benefit of Avillion and AstraZeneca’s PT027 albuterol / budesonide MDI for the treatment of asthma in adults outweighs the risks. However, the… Read more . . .
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According to Codagenix, the FDA has granted Fast Track designation to the company’s CodaVax-RSV live-attenuated intranasal vaccine candidate against respiratory syncytial virus (RSV). Earlier this year, the FDA cleared an IND for CodaVax-RSV. The company… Read more . . .
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On October 11, 2022, the FDA issued a lengthy warning letter to Nephron SC, a manufacturer of inhalation solutions and suspensions as well as a contract manufacturer of other sterile drug products. The letter does… Read more . . .
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