FDA accepts for review an Elevar Therapeutics NDA for rivoceranib, an oral tyrosine kinase inhibitor in combination with camrelizumab, a PD-1 inhibito...
FDA warns Mumbai, India-based Centaur Pharmaceuticals about CGMP deviations in its manufacturing of active pharmaceutical ingredients.
FDA warns San Jose, CA-based Outset Medical it is illegally marketing two medical devices associated with hemodialysis.
FDA gives Catalent a four-page Form FDA-483 after inspecting the firms Bloomington, IN manufacturing facility 5/4-12.
Quidel Cardiovascular recalls the Quidel Triage Cardiac Panel after reports of inaccurate tests showing lower-than-expected troponin levels in samples...
FDA updates its final guidance entitled Qualification of Medical Device Development Tools (MDDTs).
Former FDA chief counsel Dan Troy joins Berkeley Research Group in the firms Washington, DC office as a managing director in its Health Analytics pra...
FDA approves an AstraZeneca BLA for Beyfortus (nirsevimab-alip) for preventing Respiratory Syncytial Virus lower respiratory tract disease in neonates...
