Regulatory
-
Just over a week after receiving 510(k) clearance for a Hailie inhaler sensor for use with Ellipta DPIs, Adherium said that it filed a 510(k) submission to the FDA for a new Hailie sensor to… Read more . . .
-
Renovion announced that the company has gotten the go-ahead from the FDA to initiate a Phase 3 clinical trial of its ARINA-1 nebulized glutathione / bicarbonate / ascorbic acid for the prevention of bronchiolitis obliterans… Read more . . .
-
Hailie inhaler monitoring system maker Adherium announced that the FDA has cleared the company’s new version of the Hailie sensor for use with Ellipta dry powder inhalers. Adherium submitted the 510(k) application to the FDA… Read more . . .
-
According to Liquidia, the US Patent Trial and Appeal Board (PTAB) has found that none of the claims included in US Patent No. 10,716,793, covering Tyvaso inhaled treprostinil, are valid. The company said that the PTAB ruling would have… Read more . . .
-
According to Beyond Air, the FDA has approved the company’s LungFit PH inhaled nitric oxide (iNO) generation and delivery system for the treatment of babies with persistent pulmonary hypertension of the newborn (PPHN). The approval is… Read more . . .
-
Altamira Therapeutics (formerly Auris Medical) announced that the company has received 510(k) clearance to sell its Bentrio Allergy Blocker nasal spray over the counter for the treatment of allergic rhinitis in the US. The company… Read more . . .
-
Padagis, formerly Perrigo’s generic prescription pharmaceutical business, has announced the launch of a generic version of Narcan naloxone nasal spray for the reversal of opioid overdose. The Padagis generic is the second approved in the… Read more . . .
-
Savara announced that the UK Medicines and Healthcare Products Regulatory Agency has awarded an Innovation Passport to molgramostim inhaled recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP). The Innovation… Read more . . .
-
Opiant Pharmaceuticals said that it has filed the first part of a 505(b)(2) NDA for OPNT003 intranasal nalmefene for the treatment of opioid overdose and that it expects to complete the submission later this year.… Read more . . .
-
According to Codagenix, the FDA has cleared the company’s IND for CodaVax-RSV intranasal live-attenuated vaccine (LAIV) for the prevention of respiratory syncytial virus (RSV) infection, and plans are in progress for a Phase 1 study… 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
October 21-October 22: MVIC Symposium, Lund, Sweden
October 28-October 30: Deutches Aerosol Therapie Symposium (DATS), Marburg, Germany
November 10-November 11: Rescon Europe 2026, Porto, Portugal
December 9-December 11: DDL 2026, Edinburgh, Scotland