Centocor Remicade approval
Centocor's Remicade (infliximab) sBLA approved June 28 for "inducing and maintaining clinical remission in patients with moderately to severely active Crohn's disease." The supplemental application was submitted Dec. 28, 2001 and received a priority review. Remicade was approved for "reducing signs and symptoms" of Crohn's disease in August 1998...
You may also be interested in...
Pink Sheet reporters and editor discuss President-Elect Joe Biden’s decision to name the CDER director as acting FDA commissioner and other staffing changes, as well as changes to industry trade groups’ political donations.
Delfi Diagnostics will use the new funds to expand its team of cancer researchers and machine-learning experts to validate its novel approach for early cancer detection through multiple prospective clinical trials.
US Ninth Circuit affirms a district court’s summary judgment in favor of Target and manufacturer of Up & Up brand biotin supplement it sells. Indian manufacturer targeted in putative class-action in New York prompted FDA’s 2016 creation of import alert category for Ayurvedic supplements.