Regulatory

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 . . .

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… Read more . . .

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.… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .