December 2016
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US-based CDMO Kenox Pharmaceuticals announced that it is now able to offer clinical manufacturing for OINDPs and has expanded its testing services for OINDPs, including in vitro BE. In January 2025, the company said that it… Read more . . .
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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 . . .
Featured event:
5th Annual Inhaled & Nasal Biologics | DNA Forum
5th Annual Inhaled & Nasal Biologics | DNA Forum
24th-25th September 2026, Cambridge, UK
Join us for a ground-breaking and insightful forum: Two days of cutting-edge talks and networking opportunities in this complex area of drug and vaccine development.
With renowned industry leaders who will share their insights and real-world case studies, our speakers will explore innovative formulation and delivery technologies and the rationale behind overcoming development challenges. Don’t miss out on this opportunity to learn more about key topics shaping the future of inhaled therapeutics.
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Upcoming Events
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October 19-October 20: MVIC Autumn Training 2026, Lund, Sweden
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