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FDA Commissioner Stephen Hahn yesterday said the agency has identified 20 products that are either made in finished-dosed or source their active pharmaceutical ingredients solely in China. The agency has reached out to the 183 drugmakers in China and none have reported shortages tied to the COVID-19 outbreak so far, he said. Read More
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