News
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Just over a week after receiving 510(k) clearance for a Hailie inhaler sensor for use with Ellipta DPIs, Adherium said that it filed a 510(k) submission to the FDA for a new Hailie sensor to… Read more . . .
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Renovion announced that the company has gotten the go-ahead from the FDA to initiate a Phase 3 clinical trial of its ARINA-1 nebulized glutathione / bicarbonate / ascorbic acid for the prevention of bronchiolitis obliterans… Read more . . .
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According to Tonix Pharmaceuticals, the United States Patent and Trademark Office has issued the company US Patent 11,389,473,”Magnesium-Containing Oxytocin Formulations and Methods of Use,” which includes claims related to the use of such formulations for… Read more . . .
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Krystal Biotech said that the FDA has cleared an IND submitted by the company at the beginning of July 2022 and that it now intends to initiate a Phase 1 trial of its KB407 nebulized… Read more . . .
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Atossa Therapeutics said that it has completed the first three parts of a Phase 1/2a trial, which was announced in July 2021, but it will skip the remaining part. Part D had been expected to… Read more . . .
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ACM Biolabs has announced the initiation of a Phase 1 trial of its ACM-001 vaccine candidate against SARS-CoV-2. The SAD study will compare ACM-001 to an intramuscular vaccine as a booster in 80 healthy adults… Read more . . .
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DPI developer Iconovo announced that it has received a $883,800 grant from the Bill & Melinda Gates Foundation for development of a nasal inhaler based on the company’s ICOone single dose device. In March 2021, Iconovo… Read more . . .
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InCarda Therapeutics has announced the initiation of the Phase 3 RESTORE-1 trial of its InRhythm flecainide inhalation solution in patients with new or recurrent atrial fibrillation. According to InCarda, the FDA has agreed that the… Read more . . .
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Hailie inhaler monitoring system maker Adherium announced that the FDA has cleared the company’s new version of the Hailie sensor for use with Ellipta dry powder inhalers. Adherium submitted the 510(k) application to the FDA… Read more . . .
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Revelation Biosciences announced that the Phase 1b CLEAR challenge study of its REVTx-99b intranasal phosphorylated hexaacylated disaccharide (PHAD) in participants with allergies to rye grass pollen showed that the nasal drops were safe and well… Read more . . .
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