Regulatory

Milestone Pharmaceuticals says that it completed a Type A meeting with the FDA and subsequently submitted its response to the agency’s complete response letter regarding Milestone’s NDA for Cardamyst etripamil nasal spray for the treatment of… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .