News
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According to InCarda, data from the Phase 3 RESTORE-1 trial of FlecIH-103 flecainide inhalation solution for aroxysmal atrial fibrillation (PAF), which was initiated in July 2022, support continued development despite the early termination of the… Read more . . .
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ARS Pharmaceuticals has launched Neffy epinephrine nasal spray in the US, the company said. In Auguest 2024, Neffy was approved by the FDA for the treatment of anaphylaxis in patients who weigh 30 kg or… Read more . . .
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PureIMS has announced that personalized medicine company Fagron has acquired exclusive rights to distribute PureIMS’s Cyclops dry powder inhaler with compounded inhalation powders in the Netherlands. The Cyclops DPIs, which are pre-filled with drug, will be… Read more . . .
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Vistagen has announced the initiation of the Phase 3 PALISADE-4 trial of fasedienol pherine nasal spray in people with social anxiety disorder (SAD). According to the company, the PALISADE-4 trial is similar to the PALISADE-3 trial,… Read more . . .
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DPI developer Iconovo said that the FDA “has issued a positive guidance regarding the generic substitutability of the company’s proprietary inhaler ICOpre with the original drug Breo Ellipta with respect to external design and operating… Read more . . .
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The FDA and AstraZeneca are both touting the agency’s approval of FluMist intranasal influenza vaccine for caregiver administration to children aged 2-17 and for self-administration by adults up to age 49. The agency agreed to… Read more . . .
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The FDA has advised California-based Green Pharmaceuticals to recall its SnoreStop nasal spray due to “significant microbial contamination in SnoreStop Nasal Spray lot number 2460” detected during an inspection in April 2024 and is warning… Read more . . .
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Tiziana Life Sciences announced that a study of the company’s intranasal anti-CD3 mAb will be funded by a $4 million grant from the National Institutes of Health. In June 2024, the company said that the… Read more . . .
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Pulmotect announced that it has raised $5.9 million in a Series C funding to support a Phase 2 trial of the company’s PUL-042 immunostimulant inhalation solution. According to Pulmotect, the new funds will be used… Read more . . .
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MannKind Corporation announced that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has cleared the initiation of the Phase 3 ICoN-1 trial of MNKD-101 clofazimine inhalation suspension for the treatment of nontuberculous mycobacterial (NTM) lung disease. The company noted… Read more . . .
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