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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
Two FDA advisory committees backed the removal of a black box label for Pfizer’s smoking cessation drug Chantix, citing the therapy’s risk-benefit ratio. Read More
Spectrum Pharmaceuticals failed to impress an FDA advisory committee, which unanimously voted against recommending approval of the company’s treatment to prevent recurrence of low-grade non-muscle invasive bladder cancer. Read More
The National Institute for Occupational Safety and Health is holding a public meaning on a testing protocol for universal closed system drug-transfer devices (CSTDs). Read More