Regulatory
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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 . . .
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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 . . .
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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 . . .
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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 . . .
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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 . . .
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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 . . .
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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 . . .
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According to ReCode Therapeutics, the FDA has cleared the 3rd part of an ongoing Phase 2 trial of nebulized RCT2100 CFTR mRNA therapy in cystic fibrosis patients, and enrollment has opened at US sites. The new… Read more . . .
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According to Glenmark Pharmaceuticals, China’s National Medical Products Administration (NMPA) has approved Ryaltris olopatadine hydrochloride / mometasone furoate nasal spray for the treatment of allergic rhinitis. Grand Pharmaceuticals, which acquired the Chinese rights to Ryaltris… Read more . . .
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Rein Therapeutics announced that the FDA has lifted a full clinical hold on the Phase 2 “RENEW” trial of the company’s LTI-03 inhaled dry powder caveolin-1-based peptide in patients with idiopathic pulmonary fibrosis (IPF). The… Read more . . .
Upcoming Events
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December 9-December 11: DDL 2026, Edinburgh, Scotland
April 27-30: RDD Europe 2027, Antibes, France
May 12-13: USP Joint Workshop: Quality and Product Performance Testing of Orally Inhaled and Nasal Drug Products, Rockville, MD, USA
June 30: RespireX 2027, Boston, MA, USA