Calls for papers
-
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Human Factors Engineering Principles for Combination Products: Questions and Answers,” which is the final version of a draft guidance titled “Human Factors Studies… Read more . . .
-
According to Evoke Pharma, the company has received a notice of allowance from the US Patent and Trademark Office (USPTO) for patent application No. 17/366,829 (“Nasal Formulations of Metoclopramide”). The patent will cover the composition of Evoke’s… 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 . . .
-
Oxford Science Enterprises and Harrington Discovery Institute at University Hospitals, together with the University of Edinburgh’s Old College Capital venture investment fund, have created a startup called AlveoGene to develop inhaled gene therapies based on… Read more . . .
-
US-based CDMO Renaissance Lakewood, which offers a wide range of services for nasal spray development and manufacturing, has announced a significant expansion of its laboratories in New Jersey, the company said. The expansion is part… Read more . . .
-
Copley Scientific has announced the launch of its new Patient Exhalation Simulator (PES) for use in dry powder inhaler development. According to Copley, the PES simulates exhalation into a DPI prior to inhalation of the… Read more . . .
-
US-based Avalyn Pharma has announced the appointment of former Aerami Therapeutics Chief Development Officer Melissa Rhodes as Chief Operating Officer, a newly created position. Avalyn, which is developing AP01 inhaled pirfenidone and AP02 inhaled nintedanib for… 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 Liquidia Corporation, United Therapeutics has filed a new patent infringement suit in the US District Court for the District of Delaware in response to Liquidia’s submission of an sNDA for Yutrepia treprostinil DPI to add… 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 . . .
Featured event:
Upcoming Events
Sponsored by Intertek,, hosts of
The Inhaled & Nasal Biologics | DNA Forum
Want information about upcoming OINDP-related events delivered directly to your inbox? click here
July 13-July 16: 2026 ISAM Congress, Taipei, Taiwan
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