Regulatory
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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 . . .
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Ritedose Corporation announced that it licensed an ANDA for tobramycin inhalation solution from Hikma and that the FDA has approved the company to manufacture and distribute the product. The company noted that tobramycin, which is… Read more . . .
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According to Amneal Pharmaceuticals, the FDA has tentatively approved Amneal’s ANDA for a generic of Teva’s QVAR beclomethasone dipropionate HFA MDI, 40 μg/actuation and 80 μg/actuation, for the treatment of asthma. The company notes that… Read more . . .
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Italian biotech Dompé announced that the US FDA has awarded a voucher under the new Commissioner’s National Priority Voucher (CNPV) pilot program for accelerated review of an application for the company’s intranasal cenegermin-bkbj (recombinant human… Read more . . .
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According to Beckley Psytech and atai Life Sciences, the FDA has granted Breakthrough Therapy designation to Beckley’s BPL-003 intranasal mebufotenin (5-MeO-DMT) for the treatment of treatment-resistant depression. Earlier this year, the companies announced that a Phase… Read more . . .
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