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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
A bipartisan group of Senate and House members have introduced a bill that would require drugmakers to justify price rises of more than 10 percent. Read More