FDA issues a Warning Letter to Cdymax India Pharma Private Limited after inspectors uncovered CGMP violations at the companys active pharmaceutical in...
Merck reports that its drug Winrevair (sotatercept-csrk) significantly improved a key measure of heartlung function in a mid-stage trial of patients w...
FDA releases the form FDA-483 issued following an inspection at the Milan, Italy-based NerPharMa drug manufacturing facility.
FDA approves Genmabs Epkinly (epcoritamab-bysp) for combination with lenalidomide and rituximab in adults with relapsed or refractory follicular lymph...
FDA warns Noblesville, IN-based Verdure Sciences about failing to submit an IND for a clinical study of its investigational drug Maplifa.
FDA approves an Arrowhead Pharmaceuticals NDA for Redemplo (plozasiran) for reducing dangerously high triglyceride levels in adults with familial chyl...
Roche says its investigational selective estrogen receptor degrader giredestrant significantly improved invasive disease-free survival in certain peop...
FDA warns Opa-Locka, FL-based World Perfumes about CGMP violations in its production of finished drugs as a contract manufacturer.
