A Sheppard analysis warns that regulated industry should expect closer scrutiny of statements about FDA interactions and broaden their insider-trading...
A new report from the Association for Accessible Medicines calls for changes to FDA policies, patent law, pharmacy benefit manager practices and feder...
FDA grants Pharming Group expanded approval for Joenja (leniolisib) tablets for treating activated phosphoinositide 3-kinase delta syndrome in childre...
FDA grants a priority review for a Roche sBLA for Espryng to treat myelin oligodendrocyte glycoprotein antibody-associated disease, an autoimmune dise...
BMC Medical recalls its Luna G3 APAP (Model LG3600), an auto-adjusting positive airway pressure machine for treating obstructive sleep apnea, due to a...
FDA issues a partial clinical hold on Biohavens opakalim (BHV-7000) due to nonclinical characterization of certain metabolites documented in rodent te...
FDA releases the Form FDA-483 with three observations from an inspection at New Albany, OH-based XeCare.
Writing in a in a New England Journal of Medicine article, FDA officials encourage novel approaches for developing psychedelic drugs for mental health...
