Regulatory

Optinose announced that it has submitted an sNDA for a label expansion of Xhance fluticasone propionate nasal spray (OPN-375) for the treatment of chronic sinusitis without nasal polyps. Xhance has been approved for the treatment of… Read more . . .

The FDA’s Nonprescription Drugs Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee have voted unanimously in favor of over-the-counter use of Narcan naloxone nasal spray for the reversal of opioid overdose.  In December 2022, the… Read more . . .

Orexo announced that it has submitted an NDA for its OX124 intranasal naloxone for the reversal of opioid overdose. The company notes that FDA review is likely to take a little more than a year… Read more . . .

According to Opiant Pharmaceuticals, the FDA has accepted the company’s NDA for OPNT003 intranasal nalmefene for the treatment of opioid overdose for priority review and has set a PDUFA date of May 22, 2023. In… Read more . . .

According to Krystal Biotech, the European Commission has granted orphan designation to the company’s KB407 inhaled gene therapy for the treatment of cystic fibrosis. The company said that KB407, which delivers two copies of the CFTR gene to… Read more . . .

According to Avillion and AstraZeneca, the FDA has approved Airsupra (PT027) albuterol / budesonide MDI for the treatment of asthma in adults. Avillion partnered with AstraZeneca subsidiary Pearl Therapeutics on development of PT027 in 2018. In… Read more . . .

According to Polarean Imaging, the FDA has approved the company’s NDA for its Xenoview inhaled xenon-129 gas blend, a hyperpolarized contrast agent for MRI imaging of lung ventilation. Xenoview is approved for use in patients… Read more . . .