Regulatory

On November 1, 2019, Aquestive Therapeutics filed a citizen petition asking the FDA to stay approval of a 505(b)(2) NDA submitted by Neurelis in September 2018 for Valtoco diazepam nasal spray for the treatment of… Read more . . .

After having been notified that CHMP was likely to issue a negative opinion regarding its MAA for Linhaliq dual release inhaled ciprofloxacin for the treatment of P. aeruginosa lung infections in patients with non-cystic fibrosis… Read more . . .

According to Aradigm Corporation, the company has been informed that its MAA for Linhaliq dual release inhaled ciprofloxacin for the treatment of P. aeruginosa lung infections in patients with non-cystic fibrosis bronchiectasis (NCFBE) is likely… Read more . . .

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Janssen’s Spravato esketamine nasal spray for use with either a selective serotonin reuptake inhibitor (SSRI) or serotonin and norepinephrine reuptake inhibitor (SNRI)… Read more . . .

Janssen Pharmaceutical said that it has submitted a supplemental new drug application to the FDA requesting to expand the use of Spravato esketamine CIII nasal spray for the treatment of major depressive disorder in patients… Read more . . .

GlaxoSmithKline and Innoviva announced that GSK has submitted a supplemental new drug application for the use of the Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol DPI for the treatment of asthma. The FDA initially approved Trelegy Ellipta for… Read more . . .

Savara said that the FDA provided a written response after a Type C meeting regarding the company’s planned biologics license application (BLA) submission for Molgradex inhaled recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) for the treatment… Read more . . .

AstraZeneca Canada has announced today that Health Canada has approved the use of Symbicort Turbuhaler budesonide/formoterol DPI as an anti-inflammatory reliever for the treatment of mild persistent asthma.  According to the company, the expanded use was based on… Read more . . .

According to AstraZeneca, the FDA has issued a complete response letter to the company’s NDA for PT010 budesonide/glycopyrronium/formoterol fumarate MDI for the treatment of COPD. AstraZeneca recently announced positive results from the Phase 3 ETHOS… Read more . . .