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The FDA continues to crack down on generic drugmakers that owe GDUFA fees, hitting Indian drugmaker Vista Pharmaceuticals with a warning letter for failing to pay fees for the last three fiscal years. Read More
The list of states allowing substitution of biosimilars for prescription medicines nearly doubled in the first half of 2015, as seven states joined the list of eight that passed similar laws in 2013 and 2014. Read More
Members of the House Energy & Commerce Committee are giving the FDA until Aug. 14 to provide information on whether NIH included any statements about quality control, sterility or cGMP compliance in INDs it filed with the agency. Read More
Takeda’s diabetes drug Actos, which has caused the company to pay nearly $2.4 billion to settle lawsuits over cancer risks, did not increase the risk of bladder cancer in a large postmarketing study, the drugmaker says. Read More