Regulatory
-
According to ARS Pharmaceuticals, the EMA has accepted the company’s marketing authorization application for its Neffy (ARS-1) epinephrine nasal spray for the emergency treatment of anaphylaxis. ARS recently announced that Recordati had acquired marketing rights… Read more . . .
-
Altimmune announced that it has submitted an investigational new drug application to the FDA for a Phase 1 clinical study of its AdCOVID intranasal COVID-19 vaccine candidate, which it is developing in partnership with the University… Read more . . .
-
Liquidia Technologies said that it has received a complete response letter in response to its NDA for LIQ861 treprostinil inhalation powder for the treatment of pulmonary arterial hypertension. The FDA accepted the 505(b)(2) NDA for… Read more . . .
-
The batch of new product specific guidances published by the FDA in November 2020 include guidances for generic OINDPs referencing Valtoco diazepam nasal spray, Primatene Mist epinephrine MDI, and Spiriva Respimat tiotropium bromide SMI. The… Read more . . .
-
Impel NeuroPharma announced that it has submitted an NDA for its INP104 dihydroergotamine mesylate intranasal (DHE) for the treatment of migraine headaches with or without aura, which is delivered via the company’s Precision Olfactory Delivery… Read more . . .
-
The FDA has approved Chiesi’s Bronchitol mannitol DPI for the treatment of cystic fibrosis in adult CF patients after a lengthy review process. The FDA issued a complete response letter to the original NDA in… Read more . . .
-
The EC has granted marketing authorization to Insmed’s Arikayce nebulized lipsomal amikacin for the treatment of nontuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium complex (MAC) in adult patients without cystic fibrosis who have limited treatment… Read more . . .
-
According to ATAI Life Sciences, the FDA has cleared an IND submitted by Neuronasal Inc. for its N-acetylcysteine (NAC). In January 2020, ATAI announced that it had partnered with Neuronasal on development of intranasal NAC… Read more . . .
-
According to AstraZeneca, the EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of the company’s Trixeo Aerosphere formoterol fumarate/ glycopyrronium bromide / budesonide MDI for the treatment of patients with moderate to… Read more . . .
-
Liquidia Technologies said that the US Patent Trial and Appeal Board (PTAB) has issued decisions on two patents related to Tyvaso treprostinil inhalation solution, which is marketed by United Therapeutics for the treatment of pulmonary arterial hypertension… Read more . . .
Upcoming Events
Sponsored by Intertek
Want information about upcoming OINDP-related events delivered directly to your inbox? click here
December 9-December 11: DDL 2026, Edinburgh, Scotland
April 27-30: RDD Europe 2027, Antibes, France
May 12-13: USP Joint Workshop: Quality and Product Performance Testing of Orally Inhaled and Nasal Drug Products, Rockville, MD, USA
June 30: RespireX 2027, Boston, MA, USA