[ Price : $8.95]
Two months ahead of its user fee review goal, FDA approves Puma Biotechnologys Nerlynx (neratinib) in combination with capecitabin...[ Price : $8.95]
FDA commissioner Stephen Hahn says FDA is using the best available science to evaluate possible non-drug regulatory pathways for C...[ Price : $8.95]
Vizient says a consequence of FDA approval of four drugs under its Unapproved Drugs Initiative is an increase in health system spe...[ Price : $8.95]
Y-mAbs Therapeutics says it will complete in 10 weeks a rolling BLA for omburtamab for treating patients with central nervous syst...[ Price : $8.95]
FDA grants Takeda Pharmaceutical Co. a priority review for its supplemental NDA that seeks to expand the use of Alunbrig (brigatin...[ Price : $8.95]
FDA warns Indias Essnd Global about CGMP violations in its work as a contract manufacturer of finished drugs.[ Price : $8.95]
FDA warns Unetixs Vascular about Quality System violations in its manufacturing of vascular diagnostic ultrasound systems.[ Price : $8.95]
FDA warns KVK-Tech about CGMP violations in its production of finished drugs.