Regulatory

The EMA has announced that its Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion regarding a marketing authorization application submitted by Teva Pharma B.V. for a budesonide/formoterol DPI for the… Read more . . .

Pulmatrix has announced that its Pulmazole (PUR1900) dry powder itraconazole for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in patients with asthma has received Fast Track designation from the FDA. The company initiated a Phase… Read more . . .

The UK’s National Institute for Health and Care Excellence (NICE) has announced that it is not recommending the use of Janssen’s Spravato esketamine nasal spray for the treatment of treatment-resistant depression due to concerns about… Read more . . .

Liquidia Technologies said that it has submitted a 505(b)(2) NDA for its LIQ861 inhaled dry powder treprostinil for the treatment of pulmonary arterial hypertension (PAH). The company announced in March 2019 that the Phase 3 INSPIRE… Read more . . .

Health Canada has approved Baqsimi intranasal dry powder glucagon for the treatment of severe hypoglycemia in patients with Type 1 or Type 2 diabetes, Eli Lilly Canada has announced. Baqsimi is now available in Canadian… Read more . . .

According to Evoke Pharma, the FDA has accepted its resubmitted NDA for Gimoti metoclopramide nasal spray for the treatment of diabetic gastroparesis and has set a PDUFA date of June 19, 2020. The original 505(b)(2)… Read more . . .

Janssen Pharmaceutical announced that the company has submitted a type II variation application for Spravato esketamine nasal spray to the EMA seeking to expand the use of Spravato for the treatment of major depressive disorder… Read more . . .

The FDA has approved Neurelis’s Valtoco diazepam nasal spray for the treatment of seizure clusters or acute repetitive seizures in epilepsy patients aged 6 years and older. Neurelis submitted the 505(b)(2) NDA for Valtoco in… Read more . . .