Regulatory
-
The EMA and the FDA have launched a pilot program in which the agencies will give parallel scientific advice (PSA) to applicants submitting MAAs for hybrid products and ANDAs for complex generic products, including inhalers… Read more . . .
-
According to Adherium, the company has received 510(k) clearance from the FDA for its next generation Hailie inhaler sensor. The new version of the Hailie sensor, which is meant to be used with the Symbicort… Read more . . .
-
According to Impel NeuroPharma, the FDA has approved the company’s Trudhesa dihydroergotamine mesylate nasal spray for the treatment of migraine. Impel submitted the NDA for Trudhesa (INP104) in November 2020, and the agency accepted the… Read more . . .
-
The FDA has granted orphan drug designation to Aerami Therapeutics’s AER-901 inhaled imatinib for the treatment of pulmonary arterial hypertension (PAH), the company said. Aerami initiated a Phase 1 trial of AER– 901 in June… Read more . . .
-
According to Liquidia Corporation, the FDA has completed a pre-approval inspection of Liquidia’s facility in Morrisville, North Carolina, USA, where the company will manufacture LIQ861 dry powder treprostinil if approved. No Form 483 observations were issued. The… Read more . . .
-
Virpax Pharmaceuticals said that it is encouraged by the FDA response to its IND for MMS019 “high-density molecular masking spray” which the company is developing as an anti-viral barrier. According to Virpax, the company now intends… Read more . . .
-
According to a LinkedIn post by generic device maker Merxin, the FDA has indicated that Merxin’s MRX004 soft mist inhaler is suitable for an ANDA submission for a generic version of Boehringer Ingelheim’s Spiriva Respimat… Read more . . .
-
According to Relief Therapeutics, the FDA has granted orphan drug designation for RLF-100 inhaled aviptadil for the treatment of sarcoidosis; RLF-100 is currently in Phase 2 development for that indication. Relief also recently acquired German… Read more . . .
-
Levo Therapeutics announced that the FDA has accepted the company’s NDA for LV-101 intranasal carbetocin for the treatment of excessive hunger associated with Prader-Willi syndrome (PWS) and has granted the NDA Priority Review designation, with… Read more . . .
-
The Australian Therapeutic Goods Administration has issued 7 infringement notices to Starpharma regarding advertising of the company’s Viraleze astodrimer sodium antiviral nasal spray, with fines totaling $93,240. The news comes shortly after after the UK… 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
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