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While European regulators approve new drugs at a faster clip than their Canadian counterparts, both jurisdictions pull drugs from the market for safety reasons at the same rate, a new study finds. Read More
Starting next year, FDA manufacturing experts and investigators will participate in premarket reviews of all NDAs, ANDAs and supplements from the earliest stages to identify and address potential manufacturing problems down the line. Read More
Astellas Pharma and Medivation won a new indication for their joint cancer therapy Xtandi, allowing the drug to be given to a wider swath of men with metastatic castration-resistant prostate cancer. Read More
Starting next year, FDA manufacturing experts and investigators will participate in premarket reviews of all NDAs, ANDAs and supplements from the earliest stages to identify and address potential manufacturing problems down the line. Read More
An FDA advisory panel is recommending against approval of Actavis’ NDA for a fixed-dose combination of nebivolol and valsartan to treat hypertension. Read More
The FDA has cleared Takeda and Orexigen Therapeutics’ weight-loss drug Contrave, the first new anti-obesity product to win approval in more than two years. Read More
Taiwan-based TWi Pharmaceuticals has won final FDA approval for a generic version of Par Pharmaceutical’s AIDS drug Megace ES, but the product’s launch remains on hold as the brandmaker appeals its 2011 patent infringement lawsuit. Read More
Australia’s Therapeutic Goods Administration (TGA) will aim to make a decision on an orphan drug designation request within 20 working days of receipt of the application. Read More
The UK’s cost-effectiveness watchdog is recommending against coverage of Celgene’s cancer drug Ambraxane with gemcitabine for patients with previously untreated metastatic pancreatic cancer, citing its expensive price and limited benefits compared with current treatments. Read More