August 2012
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Atossa Therapeutics said that it has gotten the go-ahead for a Phase 1 clinical study of its AT-301 nasal spray, which the company is developing for the treatment of COVID-19, and expects to begin enrollment… Read more . . .
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The FDA has approved Janssen Pharmaceutical’s sNDA for the expanded use of Spravato esketamine CIII nasal spray for the treatment of major depressive disorder with acute suicidal ideation or behavior, the company said. Spravato was initially approved… Read more . . .
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TFF Pharmaceuticals said that the final subject has been dosed in a Phase 1 SAD/MAD study of its voriconazole inhalation powder, which the company is developing for the treatment of invasive pulmonary aspergillosis (IPA). The… Read more . . .
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AstraZeneca has announced that its Breztri Aerosphere (PT010) budesonide / glycopyrrolate / formoterol fumarate MDI has been approved by the FDA for the treatment of COPD. The FDA had previously issued a complete response letter… Read more . . .
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According to Insmed, the EMA’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion regarding approval of the company’s Arikayce nebulized liposomal amikacin for the treatment of non-tuberculous mycobacterial (NTM) lung… Read more . . .
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Milestone Pharmaceuticals said that it has raised $25 million from RTW Investments in a private placement and indicated that the proceeds would be sufficient for company operations through the second quarter of 2022. The company… Read more . . .
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United Therapeutics announced that it has been issued a new US patent covering Tyvaso treprostinil inhalation solution for the treatment of pulmonary arterial hypertension and that it has subsequently amended its recently filed suit against Liquidia… Read more . . .
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VistaGen Therapeutics said that the FDA has agreed to details of a proposed Phase 3 trial of the company’s PH94B aloradine nasal spray for the treatment of social anxiety disorder (SAD). PH94B was granted Fast Track… Read more . . .
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Health Canada has issued a Notice of Compliance for Janssen Pharmaceutical’s Spravato esketamine nasal spray for the treatment of major depressive disorder, and the product is now available to Canadian patients, the company said. Spravato… Read more . . .
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MannKind Corporation has announced the appointment of Alejandro Galindo as Chief Commercial Officer. Galindo most recently headed the Intensive Insulin Management business unit at Medtronic and previously served in a number of roles at GE Healthcare.… Read more . . .
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