Regulatory

According to Savara, the FDA has issued an RTF letter in response to the company's BLA for Molbreevi molgramostim inhalation solution for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP), citing insufficient CMC data. Savara completed its rolling BLA submission for Molbreevi in March 2025. The company says that it expects to request a Type A meeting … [Read more...] about FDA issues Refuse to File letter regarding Savara’s BLA for Molbreevi molgramostim inhalation solution for the treatment of aPAP

At the end of March 2025, the FDA accepted Liquidia Corporations's resubmitted 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). According to Liquidia, the agency has now approved Yutrepia for both indications. The FDA … [Read more...] about FDA approves Liquidia’s Yutrepia treprostinil DPI for PAH and for PH-ILD

According to Ritedose Pharmaceuticals, the FDA has approved an ANDA for the company's generic albuterol sulfate inhalation solution, 0.5%. In April 2023, Ritedose announced that it had begun manufacturing 5 mg/ml albuterol sulfate inhalation solution ampules for sales directly to hospitals under the 503B compounding pharmacy process. The company already marketed … [Read more...] about FDA approves Ritedose’s generic albuterol sulfate inhalation solution, 0.5%

Ritedose Pharmaceuticals has announced that the FDA approved the transfer of an ANDA for formoterol fumarate inhalation solution to Ritedose in April 2025. The company says that it expects to start shipping formoterol fumarate inhalation solution by mid-2025.   In the announcement, Ritedose notes that it purchased the ANDA in 2024 from another manufacturer. … [Read more...] about FDA approves Ritedose’s ANDA for formoterol fumarate inhalation solution

According to Satsuma Pharmaceuticals, the FDA has approved the company's NDA for Atzumi dihydroergotamine nasal powder (STS101) for the treatment of migraine in adults. Although the Phase 3 SUMMIT trial of STS101 failed to meet its primary endpoints, Satsuma submitted an NDA for the intranasal DHE in March 2023, and the FDA issued a CRL to that application in January … [Read more...] about FDA approves Satsuma’s Atzumi intranasal dry powder DHE for the treatment of migraine

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