FDA says it is reviewing the safety of Roches Actemra (tocilizumab) for treating adults with moderate to severe rheumatoid arthritis.
Medical journal editors set two publication requirements for clinical trials to move toward universal data sharing.
FDA approves an Ethicon PMA for its Surgicel Powder Absorbable Hemostat.
FDA makes technical changes to HDE and IRB regulations to meet requirements in the 21st Century Cures Act.
Attorney Kurt Karst says an Amgen suit against FDA over Sensipar pediatric exclusivity has been suspended while the company proceeds through the FDA f...
FDA warns Prestige Brand Holdings that the listing information for two of its childrens cold or flu products is inaccurate.
FDAs Los Angeles District Office warns Yusef Manufacturing Laboratories about CGMP violations in its production of finished pharmaceuticals.
Acorda Therapeutics says it plans to file an NDA by the end of the month for CVT-301 (levodopa inhalation powder) after Phase 3 data showed a statisti...