Regulatory
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Tiziana Life Sciences announced that it will dose a patient with moderate Alzheimer’s disease with intranasal foralumab under an expanded access IND. The company previously used the expanded access program to provide intranasal foralumab to… Read more . . .
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According to Verona Pharma, the FDA has approved the company’s NDA for Ohtuvayre (ensifentrine, RPL554), a PDE3/PDE4 inhibitor delivered via jet nebulizer, for the treatment of COPD. Verona submitted the NDA for ensifentrine in June… Read more . . .
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OBG subsidiary Ayrton Saunders announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved a Type II variation to the 2014 marketing authorization for the Voke nicotine inhaler, which is approved for… Read more . . .
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According to Agomab Therapeutics, the company’s AGMB-447 inhaled ALK5 inhibitor has received orphan drug designation from the FDA for the treatment of idiopathic pulmonary fibrosis (IPF). Agomab initiated a Phase 1 trial of AGMB-447 in… Read more . . .
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According to Liquidia Corporation, a judge in the US District Court for the District of Delaware has denied a United Therapeutics motion seeking a preliminary injunction to prevent Liquidia from launching Yutrepia treprostinil DPI for the treatment… Read more . . .
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Milestone Pharmaceuticals announced that the FDA has accepted the company’s NDA for Cardaymyst etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT). Milestone originally submitted the NDA in October 2023, and the FDA issued a… Read more . . .
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According to SpliSense, the FDA has granted Fast Track designation to the company’s SPL84 inhaled antisense oligonucleotide for the treatment of cystic fibrosis. SPL84 had already received Orphan Drug designation from both the FDA and… Read more . . .
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Amphastar Pharmaceuticals announced that the FDA has approved the company’s ANDA for a generic version of Teva’s ProAir HFA albuterol MDI for the treatment of asthma and said that it plans to launch the inhaler in… Read more . . .
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EVŌQ Bio said that it had positive feedback from the FDA following a pre-IND meeting about EVQ-218 inhaled non-ionic silver nanoparticle, which the company is developing for the treatment of pulmonary bacterial infections in cystic… Read more . . .
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ENA Respiratory announced that the US Patent and Trademark Office (USPTO) has issued a Notice of Allowance for a patent application titled “Novel molecules” (US 18/112091), which covers the company’s INNA-051 intranasal TLR2/6 agonist. According… Read more . . .
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December 9-December 11: DDL 2026, Edinburgh, Scotland