Regulatory

Neurelis announced that the FDA has approved the use of Valtoco diazepam nasal spray for the treatment of seizure clusters in children aged 2 years of age and older. The FDA approved Valtoco for use in patients 6 years old and older in January 2020, and the company initiated a Phase 1/2a trial of Valtoco in epilepsy patients aged 2-5 the next year. According to a … [Read more...] about FDA approves Neurelis’s Valtoco diazepam nasal spray for use in children aged 2-5

Aurobindo has reported to the National Stock Exchange of India that the FDA issued a Form 483 on April 11, 2025, one day after the agency completed an inspection of a manufacturing facility in North Carolina, USA. According to the company, the Form 483, which has not yet been published by the FDA, includes 11 observations that "are procedural in nature." The Raleigh … [Read more...] about Aurobindo says FDA issued Form 483 following inspection of North Carolina inhaler manufacturing facility

Liquidia Corporation announced that FDA has accepted a resubmission of its NDA for Yutrepia dry powder treprostinil for inhalation for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) with a PDUFA goal date of May 24, 2025. The FDA tentatively approved Yutrepia for the treatment of PAH … [Read more...] about FDA accepts Liquidia’s resubmitted NDA for Yutrepia treprostinil DPI for the treatment of PAH and PH-ILD

Milestone Pharmaceuticals announced that it has received a complete response letter from the FDA in regard to the company's NDA for Cardamyst etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT). Milestone first submitted the NDA in October 2023 and re-submitted the NDA in March 2024 after the FDA refused to accept the initial … [Read more...] about FDA issues CRL to Milestone’s NDA for Cardamyst etripamil nasal spray for PSVT

Savara announced that it has completed its BLA submission for Molbreevi molgramostim inhalation solution for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP). The company had announced the initiation of the rolling submission in December 2024. In June 2024, Savara announced that the Phase 3 IMPALA-2 study had met its primary endpoint. Molbreevi, … [Read more...] about Savara completes BLA submission for Molbreevi molgramostim inhalation solution for the treatment of aPAP

Vast Therapeutics announced that its ALX1 inhalation solution for the treatment of lung infections has received Qualified Infectious Disease Product designation from the FDA. The company describes ALX1 as a nitric oxide pro-drug, and the formulation is delivered via a PARI e-Flow nebulizer. Earlier this year, Vast announced that it had received a grant worth … [Read more...] about Vast’s ALX1 antibacterial inhalation solution gets QIDP designation

According to ReCode Therapeutics, the FDA has granted orphan drug designation to the company's RCT2100 inhaled mRNA therapy for the treatment of cystic fibrosis in patients who do not benefit from CFTR modulators. In February 2024, ReCode announced the initiation of a Phase 1 trial of RCT2100 in healthy adults. The company says that a Phase 1b study is now recruiting … [Read more...] about ReCode’s RCT2100 inhaled mRNA therapy for CF gets orphan drug designation from the FDA

According to Emergent BioSolutions, Health Canada has approved Hikma Pharmaceuticals' Kloxxado naloxone nasal spray 8 mg for the treatment of opioid overdose. In January 2025, Emergent announced that it was acquiring US and Canadian rights to Kloxxado, which has been approved in the US since 2021. Emergent, which already markets Narcan naloxone nasal spray 4 mg in … [Read more...] about Health Canada approves Hikma’s Kloxxado naloxone nasal spray, which will be marketed in Canada by Emergent BioSolutions

According to Xlear, the US Department of Justice has asked a US District Court judge to dismiss a suit filed by the US Federal Trade Commission in 2021 accusing the company of violating the COVID-19 Consumer Protection Act by claiming that its saline nasal spray with xylitol could prevent and treat COVID-19. The case (2:21-cv-00640-RJS) was brought in the US District … [Read more...] about Xlear says US DOJ has requested dismissal of FTC case against company for unsupported claims about its OTC nasal spray