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Nippon Fine Chemical impeded a December 2015 inspection, the FDA said in a warning letter that claims employees blocked access to certain areas, refused to provide documents and prevented inspectors from taking photos. Read More
The UK’s price watchdog is not recommending reimbursement for Merck’s Keytruda for the treatment of advanced or metastatic lung cancer in patients who have had at least one previous chemotherapy regimen. Read More
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