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Indian drugmaker Lupin is facing delays in expanding its presence in the U.S. market after an FDA inspection uncovered deficiencies at a company facility. Read More
The Indian government has revised its list of essential medicines, removing price caps on dozens of drugs in a number of therapeutic classes. 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 European Parliament committee is proposing that the European Commission promote transparency in private research to foster better access to medicines across the EU. 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
Diabetes drugs carry special development challenges and can be the riskiest sector in pharmaceuticals, with one in 13 investigational drugs achieving U.S. approval, according to a report from the Tufts Center for the Study of Drug Development. 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 FDA confirmed the use of total kidney volume measurements in selecting patients for clinical trials in autosomal dominant polycystic kidney disease. Read More
Kite Pharma announced positive interim results from a Phase II clinical trial of its immunotherapy in patients with aggressive non-Hodgkin’s lymphomas and said the study would form the basis of its marketing submissions to the FDA. Read More