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OncoGenex Pharmaceuticals Wednesday said the FDA has granted fast-track designation for the drugmaker’s investigational drug custirsen as a second line treatment for men with metastatic castrate-resistant prostate cancer (CRPC) and non-small cell lung cancer. Read More
Indian drug regulators have suspended distribution of three drug products made by Wockhardt, the company announced Wednesday, adding to sanctions it already faces from the FDA and UK regulators. Read More
The UK’s health cost-benefit watchdog refused to recommend Roche’s Kadcyla as a treatment for HER2-positive breast cancer, saying the $151,000 per patient cost is out of reach for the National Health Service. Read More
Massachusetts doctors who want to prescribe the painkiller Zohydro will need to complete a risk-assessment and pain management treatment agreement with their patients, under sweeping restrictions announced Tuesday by Gov. Deval Patrick (D). Read More
The FDA hopes to soon wrap up the 45-plus year process of clearing from the market older drug products that were never proven effective before being sold. Read More
The European Medicines Agency is tightening stability testing requirements for drugmakers submitting applications for significant post-approval manufacturing changes that involve active substances. Read More
Hospira’s quality struggles continue as the injectable giant voluntarily recalled seven lots of generic anesthetic propofol due a defect that led to metal particles in certain vials. Read More
Pfizer Monday reached an agreement to settle a class action lawsuit alleging that the drugmaker attempted to improperly delay the launch of generics of its epilepsy drug Neurontin. Read More