FDA releases the form FDA-483 issued following an inspection at the Vet4U drug distribution facility in Clay, NY.
An unidentified major drug company calls on FDA to establish a process for redacting complete response letters for unapproved applications before they...
Senate Democrats, led by Ron Wyden (D-OR), introduce legislation aimed at forcing the Trump administration to disclose the terms of pricing agreements...
FDA denies a citizen petition seeking to withdraw approval of Covidiens VenaSeal vein-closure system, concluding the medical device remains safe and e...
FDA approves an expanded indication for Sanofis Tzield (teplizumab), allowing its use in children as young as one year old to delay the onset of stage...
FDA warns Chinas Xiamen Kang Zhongyuan Biotechnology Co. about producing drugs in insanitary conditions and making misleading or deceptive statements ...
Two pharmacy professors say FDA needs to solicit expert and client input on its new Adverse Event Monitoring System dashboard and use the input to res...
FDA accepts a Roche supplemental BLA that seeks to expand use of Gazyva to treat Systemic Lupus Erythematosus.
