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Transpire Bio has announced the FDA’s acceptance of the company’s ANDA for a generic version of GSK’s Trelegy Ellipta fluticasone furoate / umeclidinium / vilanterol dry powder inhaler. The company says that it believes that it… Read more . . .
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Milestone Pharmaceuticals’ Cardamyst etripamil nasal spray is now available in US pharmacies, and a national sales campaign is expected to begin within the next few weeks, the company said. The FDA approved Cardamyst for the… Read more . . .
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According to GSK, the Chinese National Medical Products Administration (NMPA) has approved 100/62.5/25 mcg and 200/62.5/25 mcg strengths of Trelegy Ellipta fluticasone furoate / umeclidinium / vilanterol DPI for the treatment of adult patients with asthma. The… Read more . . .
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Copley Scientific, which introduced its new dissolution testing apparatus for OINDPs at DDL 2025, has announced the official launch of the Inhaled Dissolution Apparatus (IDA). The company points out that many developers of generic inhaled… Read more . . .
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Rein Therapeutics announced that the EMA has granted orphan drug designation to the company’s LTI-03 inhaled dry powder caveolin-1 scaffolding domain peptide for the treatment of idiopathic pulmonary fibrosis. LTI-03 already has orphan designation from… Read more . . .
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Nasus Pharma said that data from the first cohort dosed in its Phase 2 clinical study of NS002 epinephrine nasal powder demonstrate greater mean peak plasma concentration and faster time to peak concentration for the… Read more . . .
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According to DPI specialist Iconovo, the European Patent Office has indicated that it plans to approve the company’s patent application for the ICOpre inhaler platform. In 2024, the FDA indicated that the ICOpre device is… Read more . . .
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CDMO Kindeva has announced that David Stevens has taken over the role of CEO, effective January 1, 2026. Stevens succeeds Milton Boyer, who will remain a member of the board of directors, the company said. Stevens… Read more . . .
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US-based OINDP instrument and testing specialist Proveris Scientific has been acquired by Investindustrial, which describes itself as “one of Europe’s leading independent investment groups focused on taking majority or control positions, in quality leading mid-market companies.”… Read more . . .
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Frazier Life Sciences has launched a new company called AirNexis Therapeutics, which will develop inhaled suspension and dry powder formulations of HSK39004, a dual PDE3/4 inhibitor for the treatment of COPD that it has licensed… Read more . . .
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