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...
Rep. Diana Harshberger introduces legislation to aid the dietary supplement industry by changing FDAs drug preclusion rules.
Ovid Therapeutics executive chairman Jeremy Levin says FDA needs to speed its regulatory processes if it wants to persuade companies to conduct Phase ...
FDA grants Bayer an accelerated approval for Hyrnuo (sevabertinib), a kinase inhibitor for certain adult patients with locally advanced or metastatic ...
