Regulatory

According to Savara, the FDA has accepted the company’s BLA for Molbreevi molgramostim inhalation solution for the treatment of autoimmune pulmonary alveolar proteinosis. In March 2025, Savara announced that it had completed a rolling BLA submission… Read more . . .

 According to Krystal Biotech, the FDA has granted regenerative medicine advanced therapy (RMAT) designation to the company’s KB707 inhaled gene therapy for the treatment of non-small cell lung cancer. The company notes that the designation… Read more . . .

According to ALK, the EMA’s Committee for Medicinal Products for Human Use has recommended approval of a 1 mg dose of EURneffy adrenaline nasal spray for the treatment of anaphylaxis in children who weigh between 15 kg… Read more . . .

According to Nuance Pharma, China’s National Medical Products Administration has accepted the company’s NDA for Ohtuvayre inhaled ensifentrine for the treatment of COPD. Nuance announced in May 2025 that the Phase 3 ENHANCE-CHINA study of nebulized ensifentrine… Read more . . .

Transpire Bio has announced the FDA’s acceptance of the company’s ANDA for a generic version of GSK’s Trelegy Ellipta fluticasone furoate / umeclidinium / vilanterol dry powder inhaler. The company says that it believes that it… Read more . . .

According to GSK, the Chinese National Medical Products Administration (NMPA) has approved 100/62.5/25 mcg and 200/62.5/25 mcg strengths of Trelegy Ellipta fluticasone furoate / umeclidinium / vilanterol DPI for the treatment of adult patients with asthma. The… Read more . . .

Rein Therapeutics announced that the EMA has granted orphan drug designation to the company’s LTI-03 inhaled dry powder caveolin-1 scaffolding domain peptide for the treatment of idiopathic pulmonary fibrosis. LTI-03 already has orphan designation from… Read more . . .

Milestone Pharmaceuticals announced that the European Medicines Agency has accepted the company’s marketing application for its etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT), with a decision expected in early 2027. If approved, the… Read more . . .

GH Research announced that the FDA has lifted a clinical hold on the company’s IND for GH001 inhaled mebufotenin (5-MeO-DMT) for the treatment of treatment-resistant depression and that initiation of a Phase 3 trial is… Read more . . .

The Chinese National Medical Products Administration (NMPA) has approved a 2 mg dose of ARS Pharmaceuticals’s neffy epinephrine nasal spray for the treatment of anaphylaxis in patients who weigh 30 kg or more, the company said.… Read more . . .