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The FDA published final guidance on its priority review voucher program for tropical diseases, saying that a voucher does not offer a complete guarantee of an approval within six months. Read More
The FDA issued a warning about the risk of hepatitis B virus (HBV) becoming an active again in any patient who has a current or previous infection with HBV and is treated with certain direct-acting antiviral (DAA) medicines for the hepatitis C virus. Read More
The UK’s price watchdog is recommending the reimbursement of AstraZeneca’s Tagrisso as a second-line treatment for an aggressive form of lung cancer. Read More
Mappel Industria, a Brazil-based company received a warning letter from the FDA due to significant violations of cGMP regulations for finished pharmaceuticals. Read More
Sen. Charles Grassley (R-Iowa) is pressing Mylan and the Centers for Medicare and Medicaid Services for answers on the misclassification of the company’s EpiPen as a generic for the agency’s drug rebate program. Read More