Calls for papers
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According to United Therapeutics, the FDA has accepted the company’s sNDA for Tyvaso treprostinil inhalation solution for the treatment of idiopathic pulmonary fibrosis. The FDA granted orphan drug designation to treprostinil for the treatment of… Read more . . .
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Aurobindo Pharma announced that its newly-acquired US subsidiary Lannett has launched 100/50 mcg and 250/50 mcg strengths of a generic version of Advair Diskus fluticasone propionate / salmeterol xinafoate DPI in the US. Aurobindo notes that… Read more . . .
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According to ENA Respiratory, the company has received AU$2.98 million in funding from the new Australian “national virtual incubator” Biointelect Venturer, with the funds going to support a Phase 1b study of ENA’s INNA-051 dry powder… Read more . . .
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Milestone Pharmaceuticals has announced the initiation of the Phase 3 ReVeRA-301 study of etripamil nasal spray in patients with atrial fibrillation with rapid ventricular rate (AFib-RVR). The trial is expected to enroll about 150 patients who… Read more . . .
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Silo Pharma gets notice of allowance for Canadian patent covering SPC-15 intranasal therapy for PTSD
According to Silo Pharma, the company has received a notice of allowance from the Canadian Intellectual Property Office related to a patent application titled “Prophylactic Efficacy of Serotonin 4 Receptor Agonists Against Stress,” covering SPC-15… Read more . . .
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According to Rein Therapeutics, the FDA has granted the company’s LTI-03 inhaled dry powder synthetic peptide Fast Track designation for the treatment of idiopathic pulmonary fibrosis. The company notes that the FDA previously granted orphan… Read more . . .
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Inhalation specialist CDMO Bespak announced that its Holmes Chapel, UK site has again received a Gold EcoVadis sustainability rating, the second since Bespak was spun out from Recipharm in 2024. Earlier this year, Bespak and… Read more . . .
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NeOnc Technologies announced that the Phase 2a NEO100-01 study of NEO100 intranasal perillyl alcohol in patients with Grade 3 and Grade 4 IDH1-mutant gliomas met its primary endpoint, achieving a 48.9% 6-month progression-free survival rate.… Read more . . .
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Scienture Holdings announced that the company has launched Rezenopy naloxone nasal spray in the US. Scienture acquired the US rights to Rezenopy from Summit Biosciences, a subsidiary of Kindeva Drug Delivery, in 2025. The FDA approved Summit’s… Read more . . .
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Zydus Lifesciences has announced the launch of its Revahale revefenacin inhalation solution in India. The company highlights that Revahale is the country’s first once-daily nubulized LAMA for the treatment of COPD, noting that the inhalation… 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