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A planned settlement between Aegerion Pharmaceuticals and federal officials will require the company to shell out $40 million and plead guilty to two misdemeanor violations of the FD&C Act, the company disclosed Friday. Read More
The UK’s National Institute for Health and Care Excellence says it will not recommend Bristol-Myers Squibb’s Opdivo, casting doubt on the drug’s cost-effectiveness for people with locally advanced or metastatic non-squamous, non-small-cell lung cancer after chemotherapy. Read More
Oeyama-Moto is in the hot seat yet again after the FDA accused the company of violating a clinical hold the agency had placed on a clinical trial. Read More
The FDA has hit Oeyama-Moto Cancer Research Foundation’s IRB for failing to define its operational protocol, leading to inadequate communication with clinical investigators and meager documentation. Read More
As the FDA ramps up its preparations for renewing PDUFA, industry and related groups are pushing for a greater focus on patient perspectives to inform clinical research. Read More
Sponsors with pending NDAs and ANDAs backed by trials conducted at India’s Semler Research Limited must return to the drawing board because of data integrity issues, the FDA said. Read More