August 2012
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According to Defender Pharmaceuticals, the FDA has accepted the company’s NDA for DPI-386 scopolamine nasal gel for the treatment of motion sickness for priority review, with a PDUFA goal date of January 26, 2024. Defender… Read more . . .
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Liquidia Corporation said that the FDA has accepted its sNDA to add pulmonary hypertension associated with interstitial lung disease (PH-ILD) as an indication for Yutrepia treprostinil inhalation powder without requiring any additional studies and has set… Read more . . .
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Krystal Biotech said that the FDA has cleared an IND for KB408 nebulized gene therapy for the treatment of alpha-1 antitrypsin deficiency, and the company said that it plans to initiate a Phase 1 trial… Read more . . .
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Seelos Therapeutics asserts that the second part of its Phase 2 trial of SLS-002 intranasal racemic ketamine for the treatment of acute suicidal ideation and behavior in major depressive disorder would have met its primary… Read more . . .
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The International Society for Aerosols in Medicine (ISAM) welcomed more than 260 attendees to its 2023 biannual congress August 26-30 in Saarbrücken, Germany, reports organizing committee member Claus-Michael Lehr of the Helmholtz Institute for Pharmaceutical… Read more . . .
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ReCode Therapeutics announced that it has raised $50 million as an extension to a Series B financing, with funds going toward clinical development of its inhaled mRNA therapies for the treatment of primary ciliary dyskinesia… Read more . . .
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According to ARS Pharmaceuticals, the FDA has issued a complete response letter to the company’s NDA for Neffy epinephrine nasal spray for the treatment of allergic reactions, including anaphylaxis, and the agency has requested the completion of a… Read more . . .
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The Western Australian Future Health Research and Innovation Fund has awarded a A$499,241 Innovation Seed Fund grant to Virex Pharma for development of Glyxine, an inhaled antiviral nanoemulsion, for the treatment of respiratory syncytial virus. According to… Read more . . .
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Pulmatrix said that it has received a Study May Proceed letter from the FDA for a Phase 2 study of its PUR3100 dihydroergotamine mesylate inhalation powder for the treatment of migraine. Pulmatrix announced results from… Read more . . .
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Virpax Pharmaceuticals announced that it has spun off a wholly-owned subsidiary called Novvae Pharmaceuticals that will develop Virpax’s over-the-counter products, starting with AnQlar antiviral nasal spray. Virpax acquired North American rights to AnQlar, which contains… Read more . . .
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