Regulatory

Orexo announced that it has resubmitted an NDA for OX124 naloxone nasal powder for the reversal of opioid overdose. In February 2023, the company announced that it had submitted an NDA for OX124 and then… Read more . . .

The FDA issued a document on September 8, 2023 titled “Application of Human Factors Engineering Principles for Combination Products: Questions and Answers,” which is the final version of a draft guidance titled “Human Factors Studies… Read more . . .

NurExone Biologic announced that the company has received feedback from the FDA following a pre-IND meeting regarding NurExone’s ExoPTEN intranasal exosome therapy and now plans to submit an IND by the end of this year… Read more . . .

According to Verona Pharma, the FDA has accepted the company’s NDA for its nebulized ensifentrine (RPL554) for the treatment of COPD with a PDUFA target date of June 26, 2024. The company submitted the NDA… Read more . . .

According to Krystal Biotech, the FDA has granted orphan drug designation to the company’s KB408 nebulized gene therapy for the treatment of alpha-1 antitrypsin (AAT) deficiency. Krystal, which is also developing inhaled gene therapies for… Read more . . .

The FDA issued a warning letter to AstraZeneca dated August 4, 2023 that cites multiple “false or misleading claims and/or representations” about the efficacy of the company’s Breztri Aerosphere (PT010) budesonide / glycopyrrolate / formoterol fumarate… Read more . . .

According to Tiziana Life Sciences, the FDA has cleared the company’s IND to allow clinical development of intranasal foralumab in Alzheimer’s disease. Earlier this year, Tiziana announced plans to develop foralumab, an intranasal anti-CD3 monoclonal antibody,… Read more . . .

Marinomed Biotech said that its partner M8 Pharmaceuticals has received marketing authorization for Carragelose iota-carrageenan nasal spray in Mexico. M8 acquired the rights to market the nasal spray in Mexico and Brazil in 2021. According… Read more . . .

Defender Pharmaceuticals announced that it has submitted an NDA for its DPI-386 scopolamine nasal gel for the prevention of motion sickness in adults. According to the company’s web site, Defender has worked with the US… Read more . . .