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The FDA’s Oncologic Drugs Advisory Committee split on the benefit-risk profile for Eli Lilly’s monoclonal antibody Cyramza (ramucirumab), voting 6-5 in favor of the drug for patients with untreated metastatic EGFR-positive non-small cell lung cancer. Read More
The FDA issued a warning letter to a Yibin, Sichuan API manufacturer for serious recordkeeping violations related to its crude heparin manufacturing operations. Read More
The Institute for Clinical and Economic Review (ICER) has gone back on its initial value assessment for two of three acute migraine treatments, finding after a second look that the drugs may be cost-effective after all. Read More
FDA Commissioner Stephen Hahn offered more details yesterday of the agency’s plans to request paper records from Chinese drugmakers and API manufacturers while inspections in China are on hold during the COVID-19 outbreak. Read More
The first U.S. clinical trial of a treatment for COVID-19 — Gilead’s antiviral remdesivir — has begun at the University of Nebraska Medical Center in Omaha. Read More
Mallinckrodt announced a $1.6 billion settlement with 47 U.S. states and territories for its role in the nation’s opioid crisis, in a deal that involves the bankruptcy of its generics unit. Read More