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Regulatory

United Therapeutics submits sNDA for use of Tyvaso in PH-ILD

The FDA has accepted a supplemental NDA for United Therapeutics's Tyvaso treprostinil inhalation solution for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD), the company said. In February 2020, United Therapeutics announced that the Phase 3 INCREASE study of Tyvaso in PH-ILD patients had met its primary endpoint. Tyvaso … [Read more...] about United Therapeutics submits sNDA for use of Tyvaso in PH-ILD

NeuroRx gets clearance for clinical trial of inhaled aviptadil for COVID-19

The FDA has cleared an IND for NeuroRx to conduct a clinical trial of an inhaled formulation of its RLF-100 aviptadil in patients with moderate or severe COVID-19, the company said. NeuroRx recently announced that an intravenous formulation of RLF-100 has shown promising results in patients with severe COVID-19 and that researchers in Brazil have demonstrated that … [Read more...] about NeuroRx gets clearance for clinical trial of inhaled aviptadil for COVID-19

Atossa gets approval for Phase 1 study of AT-301 nasal spray

Atossa Therapeutics said that it has gotten the go-ahead for a Phase 1 clinical study of its AT-301 nasal spray, which the company is developing for the treatment of COVID-19, and expects to begin enrollment within a month. Atossa previously announced that it had contracted with Summit Biosciences for development and manufacturing of the nasal spray and with Advance … [Read more...] about Atossa gets approval for Phase 1 study of AT-301 nasal spray

FDA approves Spravato esketamine nasal spray for depression with suicidal ideation

The FDA has approved Janssen Pharmaceutical's sNDA for the expanded use of Spravato esketamine CIII nasal spray for the treatment of major depressive disorder with acute suicidal ideation or behavior, the company said. Spravato was initially approved by the FDA in March 2019 for the treatment of treatment-resistant depression, and Janssen announced the … [Read more...] about FDA approves Spravato esketamine nasal spray for depression with suicidal ideation

FDA approves Breztri Aerosphere for the treatment of COPD

AstraZeneca has announced that its Breztri Aerosphere (PT010)  budesonide / glycopyrrolate / formoterol fumarate MDI has been approved by the FDA for the treatment of COPD. The FDA had previously issued a complete response letter to AstraZeneca’s NDA for PT010 in the fall of 2019. In August 2019, the company announced that the Phase 3 ETHOS trial of Breztri had … [Read more...] about FDA approves Breztri Aerosphere for the treatment of COPD

CHMP recommends approval of Arikayce inhaled liposomal amikacin for NTM lung infections

According to Insmed, the EMA's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion regarding approval of the company's Arikayce nebulized liposomal amikacin for the treatment of non-tuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium complex (MAC) in patients who do not have cystic fibrosis. According to … [Read more...] about CHMP recommends approval of Arikayce inhaled liposomal amikacin for NTM lung infections

Milestone Pharmaceuticals raises $25 million, provides update on etripamil development

Milestone Pharmaceuticals said that it has raised $25 million from RTW Investments in a private placement and indicated that the proceeds would be sufficient for company operations through the second quarter of 2022. The company also announced that it had reached an agreement with the FDA regarding modifications to the design of a pivotal trial of its etripamil nasal … [Read more...] about Milestone Pharmaceuticals raises $25 million, provides update on etripamil development

VistaGen announces details of proposed Phase 3 trial of PH94B nasal spray for anxiety

 VistaGen Therapeutics said that the FDA has agreed to details of a proposed Phase 3 trial of the company's PH94B aloradine nasal spray for the treatment of social anxiety disorder (SAD). PH94B was granted Fast Track designation for that indication in December 2019. According to VistaGen, the Phase 3 trial will include "a single-event, laboratory-simulated public … [Read more...] about VistaGen announces details of proposed Phase 3 trial of PH94B nasal spray for anxiety

Janssen announces launch of Spravato esketamine nasal spray in Canada

Health Canada has issued a Notice of Compliance for Janssen Pharmaceutical's Spravato esketamine nasal spray for the treatment of major depressive disorder, and the product is now available to Canadian patients, the company said. Spravato is meant to be used under direct supervision of a healthcare professional, and in combination with an oral antidepressant, when … [Read more...] about Janssen announces launch of Spravato esketamine nasal spray in Canada