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The FDA is taking public questions and comments relating to implementing a global guidance from 2010 on the nonclinical evaluation of anticancer drugs, also known as the S9 guidance, developed by the International Council for Harmonisation. Read More
A joint meeting of three FDA advisory committees tackled the issue of prescribing opioid painkillers in pediatrics, and came up with a constant refrain: We need more data. Read More
New Mexico Attorney General Hector Balderas has filed a lawsuit against Bristol-Meyers Squibb, alleging the company engaged in false and deceptive marketing of its blood thinner Plavix. Read More
The expanded HHS mandate that clinical trial investigators publish their full results on ClinicalTrials.gov is backed up with strong consequences for non-compliance that will be enforced by the FDA and the National Institutes of Health. Read More
The FDA is turning up the heat on pharmaceutical firms for a range of GMP violations, firing off warning letters to three companies over issues ranging from data integrity to risk management. Read More
FDA modified the dosage regimen for Opdivo — setting 240 mg intravenously every two weeks, until disease progression or intolerable toxicity — in approved indications for renal cell carcinoma, metastatic melanoma, and non-small cell lung cancer. Read More