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Clinical trials to prove biosimilar interchangeability with reference products will likely involve multiple switches between the products, an industry expert said. Read More
Celator Pharmaceuticals has received a drug enforcement promotion letter as a result of a drug it showcased during the annual meeting of the American Society of Clinical Oncology (ASCO). Read More
An FDA inspection found microbiological contamination of drugs purporting to be sterile at a Bausch & Lomb manufacturing facility in Florida, according to a Form 483 handed to the company. Read More
The FDA has tentatively declared that vinpocetine does not classify as dietary ingredient, citing its clinical investigation as a new drug and composition as a synthetic compound. Read More
The FDA has extended the review period for Novo Nordisk’s Type 2 diabetes candidate IDegLira, just weeks after the agency delayed its decision on a comparable therapy by Sanofi. Read More