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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
The United Nations High-Level Panel on Access to Medicine is proposing that governments rely on compulsory licenses to improve patient access to medicines in a highly anticipated report that has been met with dismay from industry. Read More