Nuance Pharma Announces Approval of Ohtuvayre® (ensifentrine) in Hong Kong SAR, China
Approval marks the second regulatory approval outside of the U.S. Food and Drug Administration, further expanding access to COPD patients in select Special Administrative Regions (SARs) in Greater China SHANGHAI, March 12, 2026 /PRNewswire/ --...
Nuance Pharma Announces Acceptance for Review of the New Drug Application for Ohtuvayre® (ensifentrine) by the National Medical Products Administration of China for the maintenance treatment of chronic obstructive pulmonary disease
SHANGHAI, Jan. 27, 2026 /PRNewswire/ -- Nuance Pharma ("Nuance") today announced that the National Medical Products Administration (NMPA) of China has officially accepted for review the New Drug Application (NDA) for Ohtuvayre ® (ensifentrine) for...
Nuance Pharma Announces Ensifentrine Meets Primary Endpoint in Phase 3 ENHANCE-CHINA Trial for COPD
Statistically significant improvements in lung function Consistent trends of quality of life and exacerbation rate reduction as ENHANCE-1/2 Well tolerated safety profile NDA submission planned for 2H 2025 SHANGHAI, May 16, 2025 /PRNewswire/ --...
Nuance Pharma Announces Approval of Ohtuvayre™ (ensifentrine) in Macau SAR, China
Ohtuvayre™is indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients First inhaled COPD treatment providing bronchodilation and non-steroidal anti-inflammatory effects SHANGHAI, Feb. 7, 2025...