Drugs

FDA Accepts Orexo NDA Resubmission for Rescue Medication

FDA has accepted for review a resubmitted NDA for Izipry (naloxone nasal powder), a high-dose naloxone rescue medication for opioid overdose. The agency has set a user fee review action target date of 3/29/2027.

Izipry is being developed using Orexo’s proprietary AmorphOX powder-based drug delivery platform. It is designed to address the growing prevalence of overdoses requiring high doses of naloxone, including those involving highly potent synthetic opioids such as fentanyl, according to the company.

“The FDA’s acceptance confirms that the resubmission contains the additional information and documentation needed to review whether it addresses the observations in the agency’s July 2024 Complete Response Letter (CRL),” the company says.

Woodcock: Ways to Make Gene Therapies More Viable

Former FDA principal deputy commissioner, acting commissioner, and CDER director Janet Woodcock says reforms are needed to make individualized gene therapies a viable development opportunity for rare diseases. Writing in a BioCentury online commentary, Woodcock says FDA already has the statutory authority to address several of the barriers preventing the

Vanda, FDA Clash Over Animal Testing Requirements

Vanda Pharmaceuticals and FDA are asking a federal judge to resolve a dispute over the agency's partial clinical hold on a yearlong trial of tradipitant for gastroparesis, with the company arguing that FDA's insistence on additional animal toxicity testing violates the FDA Modernization Act 2.0

Revised Guidance on Drug-Delivery Device Performance Requirements

FDA has issued a revised a 6/2024 draft guidance outlining the performance characteristics manufacturers should evaluate, validate and control for medical devices used to deliver drugs and biological products, including drug-device combination products. The guidance, Essential Drug Delivery Performance Characteristics for Devices Intended to Deliver Drugs and Biological

FDA Warns Chirp Innovations Over Unauthorized Pain Claims

FDA has issued a Warning Letter to Utah-based Chirp Innovations LLC for promoting its cleared Halo Wireless Muscle Stimulator for menstrual pain without obtaining additional marketing clearance and for widespread deficiencies in its quality system and medical device reporting procedures. The 10/2 Warning Letter followed an 11/2025

Read more

Woodcock: Ways to Make Gene Therapies More Viable

Vanda, FDA Clash Over Animal Testing Requirements

Revised Guidance on Drug-Delivery Device Performance Requirements

FDA Warns Chirp Innovations Over Unauthorized Pain Claims