An FDA safety alert says several manufacturers have recalled several lots of immune globulin intravenous and subcutaneous products due to a higher rat...
Merck says it will seek FDA approval for new HIV regimen following its announcement of positive results from two pivotal Phase 3 trials of doravirine/...
FDA clears a Beckman Coulter Diagnostics 510(k) for its DxC 500i Clinical Analyzer.
FDA warns Indias Shree Jaya Laboratories about CGMP deviations in its production of active pharmaceutical ingredients at a facility in Yadadri Bhuvana...
FDA warns Chinas Linghai ZhanWang Biotechnology Co. about CGMP violations in its manufacturing of over-the-counter drugs.
Pfizer and Arvinas announce positive topline results from a clinical trial evaluating vepdegestrant monotherapy versus fulvestrant in certain adults w...
FDA tells Chinas Mid-Link Technology Testing Co. it is rejecting all data from all studies conducted by the company until it provides a substantive re...
Two clinical research facility owners plead guilty in Florida federal court to conspiracy to commit wire fraud in connection with their work on two cl...
