Calls for papers
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Glenmark’s generic equivalent of FloVent HFA fluticasone propionate MDI gets final approval from FDA
According to Glenmark, the FDA has approved the company’s ANDA for a generic equivalent of GSK’s FloVent HFA fluticasone propionate MDI with competitive generic therapy (GGT) designation. FloVent HFA was initially approved in 2004, and… Read more . . .
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Rein Therapeutics announced the that the first patient has been dosed in a Phase 2 study evaluating its LTI-03 caveolin-1 scaffolding domain peptide DPI in patients with idiopathic pulmonary fibrosis, with interim data expected later… Read more . . .
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AtaiBeckley said that it completed an End‑of‑Phase 2 meeting with the FDA regarding BPL‑003 intranasal mebufotenin for the treatment of treatment‑resistant depression (TRD) and that the agency indicated that it supports the company’s plan for… Read more . . .
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US biopharm Esperion will pay $75 million in cash up front and up to $180 million in milestone payments to acquire Corstasis Therapeutics and its Enbumyst bumetanide nasal spray, the companies said. The deal also… Read more . . .
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According to Pulmatrix, Cullgen has terminated the 2024 merger agreement between the companies. Pulmatrix said that it would In December 2025, Pulmatrix and Cullgen announced that Chinese authorities had still not approved the merger, and… Read more . . .
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SpliSense’s SPL84 inhaled antisense oligonucleotide for CF gets early PRIME designation from the EMA
According to SpliSense, the European Medicines Agency has granted early Priority Medicines designation to the company’s SPL84 inhaled antisense oligonucleotide for the treatment of cystic fibrosis in patients with a 3849+10Kb C>T mutation in the… Read more . . .
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A consortium called NOFLU has received €13 million from the European Health and Digital Executive Agency (HaDEA) under the EU4Health program to support development of an intranasal vaccine against influenza. The NOFLU consortium consists of… Read more . . .
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According to SoftOx Defense Solutions, the Irish Health Products Regulatory Authority has approved a clinical trial application for the company’s SIS-02 Phase 1 study of SIS hypochlorous acid inhalation solution in healthy volunteers. SoftOx recently… Read more . . .
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According to Gossamer Bio, the Phase 3 PROSERA trial of its seralutinib dry powder inhaler in patients with pulmonary arterial hypertension missed its primary endpoint of change in 6-minute walk distance from baseline. The company… Read more . . .
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Iconovo announced that it has signed a letter of intent with CDMO Lonza related to development of spray dried formulation of inhaled biologics. The companies announced in January 2025 that Lonza would develop spray dried… 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