Regulatory
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The FDA has granted Breakthrough Therapy designation to Zambon’s CMS I-neb colistimethate sodium for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in adult patients with chronic P. aeruginosa lung infections, the company said. The FDA… Read more . . .
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Tiziana Life Sciences said that the FDA has issued a Study May Proceed letter allowing Brigham and Women’s Hospital (BWH) to treat an additional eight patients with secondary progressive multiple sclerosis (SPMS) with Tiziana’s intranasal… Read more . . .
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CyanVac subsidiary Blue Lake Biotechnology is planning a Phase 1 trial of its BLB-201 intranasal vaccine against respiratory syncytial virus (RSV) after receiving FDA clearance for its IND, CyanVac said. The Phase 1 trial will… Read more . . .
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According to Ji Xing Pharmaceuticals, Chinese regulators have approved the company’s application for a Phase 3 clinical trial of OC-01 varenicline nasal spray for the treatment of dry eye disease in China. Ji Xing acquired… Read more . . .
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According to Perrigo, the FDA has approved its NDA for Nasonex 24HR Allergy mometasone furoate nasal spray for the treatment of allergy symptoms, the first branded Rx-to-OTC switch for Perrigo, and the company expects to launch… Read more . . .
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The FDA has approved a generic version of AstraZeneca’s Symbicort budesonide / formoterol fumarate MDI from Mylan (now Viatris), the agency announced. The FDA tentatively approved the Mylan ANDA in March 2021 just after a… Read more . . .
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Tonix Pharmaceuticals has provided updates on two formulations of its intranasal potentiated oxytocin. The company acquired the license for one of the formulations, TNX-1900 for the treatment of migraine, from Trigemina in June 2020. According… Read more . . .
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According to Medical Developments International (MVP), the FDA has lifted a clinical hold on MVP’s Penthrox methoxyflurane inhaler and, as a result, MVP is now preparing a Phase 3 trial of Penthrox for trauma pain… Read more . . .
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Sorrento Therapeutics announced that the FDA has given the company the okay to move ahead with a Phase 1 trial of its Covishield (STI-9199) intranasal antibody cocktail in healthy volunteers. According to Sorrento, in vitro… Read more . . .
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According to Armata Pharmaceuticals, the FDA has cleared the company’s IND for a clinical trial of AP-PA02, an inhaled phage cocktail, in non-cystic fibrosis bronchiectasis (NCFB), and the company plans to initiate a Phase 2… Read more . . .
Upcoming Events
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May 10-May 14: RDD 2026, Phoenix, AZ, USA
May 15-May 16: ATS Respiratory Innovation Summit 2026, Orlando, FL, USA
May 17-May 20: ATS International Conference 2026, Orlando, FL, USA
June 10: SMI.London 2026, London, UK
July 13-July 16: 2026 ISAM Congress, Taipei, Taiwan