FDA issues a Warning Letter to Cdymax India Pharma Private Limited after inspectors uncovered CGMP violations at the company’s active pharmaceutical ingredient plant in Bangalore.
Merck reports that its drug Winrevair (sotatercept-csrk) significantly improved a key measure of heart–lung function in a mid-stage trial of patients with a rare and hard-to-treat form of pulmonary hypertension linked to heart failure with preserved ejection fraction.
