FDA News

FDA Approves New Drug for Advanced Bladder Cancer

On Monday, May 1st, the FDA approved Imfinzi™ (durvalumab).  Imfinzi is manufactured by AstraZeneca, and it is a PD-L1 inhibitor indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma.  The immune-oncology drug is intended for use... Read More

CREATES Act Reintroduced in House & Senate

On Thursday, April 27th, the “Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act was reintroduced by members of the Senate & House Judiciary Committees.  The CREATES Act is a bipartisan bill intended to “combat anticompetitive practices used by... Read More

FDA Approves First Drug for a Form of Batten Disease

On Thursday, April 27th, the FDA announced the approval of Brineura™ (cerliponase alfa).  Brineura, manufactured by BioMarin International Ltd., is an infusion indicated for the treatment of symptomatic children ages three and older suffering from late infantile neuronal ceroid lipofuscinosis... Read More

FDA Approves 5th Biosimilar Product

On Friday, April 21st, Reneflexis® (SB2, infliximab – abda) was approved by the FDA.  Reneflexis is manufactured by Samsung Bioeipis, and is a biosimilar product to Janssen’s Remicade® (infliximab).  Reneflexis is the fifth biosimilar product, and the second infliximab biosimilar... Read More