Regulatory
-
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 . . .
-
According to Savara, the company has resubmitted its BLA for Molbreevi molgramostim inhalation solution for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP) with a request for priority review. Molbreevi has been granted Breakthrough Therapy and Fast Track… Read more . . .
-
According to Asia Scientific Global, the FDA has cleared an IND that will allow a Phase 1 trial of its Beta1 inhaled dry powder therapy for the treatment of erectile dysfunction to move forward, and… Read more . . .
-
Savara has announced two new European patents covering Molbreevi molgramostim inhalation solution. The company said that it has received notification from the European Patent Office that it intends to grant a patent covering the liquid… Read more . . .
-
Milestone Pharmaceuticals announced that the FDA has approved Cardamyst etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT) and that the company expects to launch the product in early 2026. Milestone submitted the NDA… Read more . . .
-
Amneal Pharmaceuticals announced that the FDA has approved the company’s ANDA for a generic version of Teva’s ProAir HFA albuterol MDI for the treatment of asthma. Amneal submitted the ANDA in 2023 and was sued… Read more . . .
-
According to Blue Lake Biotechnology, the FDA has agreed to lift a partial clinical hold on a Phase 1/2a clinical trial of BLB201 intranasal RSV vaccine in children aged 8 months to 59 months with… Read more . . .
Upcoming Events
Sponsored by Intertek
Want information about upcoming OINDP-related events delivered directly to your inbox? click here
October 21-October 22: MVIC Symposium, Lund, Sweden
November 10-November 11: Rescon Europe 2026, Porto, Portugal
December 9-December 11: DDL 2026, Edinburgh, Scotland