Regulatory
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According to Impel NeuroPharma, the FDA has accepted the company’s 5O5(b)(2) NDA for its INP104 intranasal dihydroergotamine mesylate (DHE) for the treatment of migraine headaches and has set a PDUFA goal date of September 6,… Read more . . .
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Receptor Life Sciences (RLS) said that a pre-IND meeting with the FDA “resulted in clear guidance on the regulatory requirements” for development of the company’s RLS103 dry powder cannabidiol (CBD) for the treatment of panic… Read more . . .
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Ovoca Bio said that its subsidiary IVIX has resubmitted a marketing application for the company’s BP-101 synthetic peptide nasal spray for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women to the Russian… Read more . . .
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United Therapeutics announced that it has agreed to pay $105 million for a rare pediatric disease priority review voucher that the company plans to use to get an 8-month FDA review of an NDA for… Read more . . .
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The FDA has issued a clinical hold on Altimmune’s IND for its AdCOVID intranasal COVID-19 vaccine candidate, the company said. Altimmune submitted the IND to the agency in November 2020. According to the company, the… Read more . . .
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According to Polyphor, the UK’s MHRA has authorized a Phase 1 study of the company’s murepavadin inhalation solution, which the company is developing for the treatment of Pseudomonas aeruginosa lung infections in cystic fibrosis patients.… Read more . . .
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Oyster Point Pharma has announced its submission of a 505(b)(2) NDA for its OC-01 varenicline nasal spray for the treatment of dry eye disease. In May 2020, Oyster Point announced positive results from the the… Read more . . .
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Hikma Pharmaceuticals announced that the FDA has approved 100 mcg/50 mcg and 250 mcg/50 mcg doses of the company’s fluticasone propionate / salmeterol DPI (VR315), a generic version of Advair Diskus and that the company… Read more . . .
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The EU has approved AstraZeneca’s Trixeo Aerosphere (PT010) formoterol fumarate / glycopyrronium bromide / budesonide MDI for the treatment of patients with moderate to severe COPD that is not treated adequately an ICS/LABA or LABA/LAMA combination, the… Read more . . .
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Codagenix and vaccine manufacturer Serum Institute of India (SIIPL) have initiated a Phase 1 trial of COVI-VAC single-dose intranasal, live attenuated vaccine against SARS-CoV-2 after receiving approval from the MHRA, the companies said. Like Codagenix’s… Read more . . .
Upcoming Events
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September 15-September 18: DDL New Researcher Network Summer Event, London, UK
September 16-September 17: IPAC-RS 2026 Nasal Innovation Forum, Jersey City, NJ, USA
September 24-September 25: Inhaled & Nasal Biologics | DNA Forum, Cambridge, UK
October 14-October 15: Advancing Bioequivalence Frameworks for Inhalation and Nasal Drug Products: Optimizing In Vitro, In Vivo, and In Silico Methods, Rockville, MD, USA
October 19-October 20: MVIC Autumn Training 2026, Lund, Sweden