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A European Medicines Agency committee has clarified what kinds of drugs may be classified as advanced-therapy medicinal products (ATMPs), including the criteria for classifying cells and tissues as "engineered." Read More
In a reversal of its 2010 guidance, the UK's cost-benefit watchdog now recommends coverage of Novartis' cancer drug Glivec in some patients following surgery for gastro-intestinal stromal tumours (GIST).
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The U.S. Patent and Trademark Office's recently established patent review board has received what appears to be its first challenge to a drug patent covering a business practice rather than a drug's attributes. Read More
Allergan got bad and good news recently from the FDA, with the agency rejecting for a second time the company's migraine treatment Semprana due to manufacturing issues but approving a new indication for its eye treatment Ozurdex. Read More
Drugmakers with products on the market in Europe have less than two months before they must start paying thousands of dollars in new fees to fund EU pharmacovigilance activities. Read More
Warning is unrelated to FDA’s investigation into risk of heart attack, stroke and death linked to blood clots in arteries in testosterone patients. Read More
Drug approved under the qualified infectious disease products designation, created in 2012 to spur development of drugs for increasingly resistant pathogens. Read More
The FDA on Friday approved Los Angeles-based MannKind Corp.’s rapid-acting inhaled insulin Afrezza Inhalation Powder to control blood sugar levels in adults with common type 2 diabetes during meals. Read More
A key European panel recommended approval for Eli Lilly and Boehringer Ingelheim’s biosimilar of Sanofi’s blockbuster long-acting insulin drug Lantus, creating a potential threat to the French drugmaker’s multi-billion dollar product. Read More