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The UK’s Medicines and Healthcare products Regulatory Agency has created a pathway to speed life-saving drugs to patients via an early-access program similar to the U.S. Food and Drug Administration’s popular breakthrough therapy initiative. Read More
The European Medicines Agency has launched a pilot program to speed new therapies to patients by authorizing products in stages for targeted populations. Read More
Manufacturers of influenza vaccine in the EU must file strain variation applications for next year’s flu season by June 16, the European Medicines Agency says. Read More
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