Regulatory

The EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion regarding an expanded indication for Janssen’s Spravato esketamine nasal spray on December 10, 2020. The proposed revision would add the use of Spravato… Read more . . .

According to United Therapeutics, the FDA has granted orphan drug designation to treprostinil for the treatment of patients with idiopathic pulmonary fibrosis (IPF), with the designation’s benefits applying to both Tyvaso inhalation solution and Treprostinil… Read more . . .

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 . . .