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The FDA wants to remove Covis Pharmaceuticals’ preterm birth drug Makena (hydroxyprogesterone caproate) from the market, contending that 11 years of postmarket data have failed to show Makena actually does what Covis claims — improve neonatal outcomes in premature births. Read More
With the FDA approval in hand, Kite intends to use the facility to focus on what is considered a crucial element in the CAR T therapy development process. Read More
Congress may have delayed reauthorization of the FDA’s user fee programs until almost the last hour, but the agency had its table of rates worked out and queued up for publication within the week. Read More
The biggest insulin producers — Eli Lilly, Novo Nordisk and Sanofi — are falling short in their efforts to expand global access to the life-saving drug, claims a new report from the Access to Medicine Foundation, a nonprofit group. Read More
Abbreviated new drug application (ANDA) applicants may request a meeting to discuss problems identified in a complete response letter (CRL), according to a final guidance that explains what should be discussed — and not discussed — during the meeting. Read More