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The UK’s price watchdog has recommended reimbursement for Alexion Pharma’s Strensiq to treat perinatal- and infantile-onset hypophosphatasia and Gilead’s Epclusa to block the spread of hepatitis C virus genotypes to new cells, provided the companies discount the prices. Read More
Earlier this summer the FDA recommended a five-point scale to rate topical patch adhesion for drugmakers submitting abbreviated new drug applications (ANDA). However, the recommendations have only raised more questions. Read More
When planning an international clinical trial, setting endpoints that are clinically meaningful across regions and planning ahead for local factors are recommended in draft FDA guidance. Read More
When planning an international clinical trial, setting endpoints that are clinically meaningful across regions and planning ahead for local factors are recommended in draft FDA guidance. 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
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