Regulatory

According to AstraZeneca, the EMA’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion regarding the marketing authorization application for the company’s Bevespi Aerosphere glycopyrronium/formoterol fumarate MDI for the treatment of… Read more . . .

The FDA has approved labeling and indication changes for Boehringer Ingelheim’s Stiolto Respimat tiotropium/olodaterol SMI, adding data about reductions in COPD exacerbations to the label. Stiolto Respimat (marketed in Europe as Spiolto Respimat) was initially… Read more . . .

Janssen Pharmaceutical has submitted an MAA to the EMA for its esketamine nasal spray for the treatment of treatment-resistant depression in adults with major depressive disorder, the company said. Janssen submitted an NDA for the… Read more . . .

According to California-based start-up CounterAct, the FDA has approved of the company’s approach regarding potential approval of its naloxone nasal spray cap. The CounterAct cap is a plastic device that snaps onto the top of… Read more . . .

The FDA has approved Insmed’s amikacin liposome inhalation suspension for the treatment of nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC) in a limited population of patients. Arikayce, which Insmed had recently… Read more . . .

According to Neurelis, the company has submitted an NDA for its diazepam nasal spray, now called Valtoco, for the treatment of cluster seizures in epilepsy patients aged six years and older. The nasal spray, previously… Read more . . .

According to GlaxoSmithKline and Innoviva, the EMA’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion regarding wider use of the Trelegy Ellipta fluticasone furoate/umeclidinium/ vilanterol DPI in moderate-to-severe COPD. Trelegy… Read more . . .

Acorda Therapeutics has announced that the PDUFA date for review of its NDA for the Inbrija levodopa DPI for the treatment of symptoms during OFF periods in Parkinson’s disease patients has been changed from October… Read more . . .

The FDA has issued dozens of new product-specific draft guidances for generic drug development, including a draft guidance for dry powder formulations of albuterol sulfate. The guidance covers development of generic equivalents to Teva’s ProAir… Read more . . .