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Apotex’s application for a biosimilar version of Amgen’s chemotherapy Neulasta has been accepted by the FDA, one of several recent signs that regulatory movement on approving the therapies is gaining momentum. Read More
Halozyme Therapeutics’ pegylated recombinant human hyaluronidase last month won orphan drug designation for pancreatic cancer from the European Medicines Agency, marking the therapy’s second orphan drug win in 2014. Read More
Development and approval times of central nervous system drugs that treat conditions such as depression, Alzheimer’s and Parkinson’s disease lag behind those of other drugs, a recent report finds. Read More
The FDA approved seven new drugs last month, pushing its total to 41 last year, the highest number of new molecular entities cleared by the agency since 1996. Read More