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Merck has responded to the FDA’s approvable letter for its new arthritis pain reliever Arcoxia with new study data and now expects a decision in April 2007.
The FDA’s decision to place a hold on a clinical trial is threatening HHS’ contract with VaxGen for the development of a stockpile of anthrax vaccines.
The average cost of developing a new therapeutic biotechnology product is more than $1.2 billion, including the costs of drugs that fail in testing and the time associated with bringing these products to market, according to a new study by the Tufts Center for the Study of Drug Development (CSDD).
Duramed Pharmaceuticals will ship its controversial contraceptive Plan B in both OTC and prescription forms after a nearly three-year approval process full of delays and demands, its parent company, Barr Pharmaceuticals, announced.
Adolor and GlaxoSmithKline’s (GSK) Entereg faces yet another obstacle, as the FDA has issued an approvable letter requiring more data for the gastrointestinal drug.
Neurocrine Biosciences saw the price of its stock fall 30 percent after announcing more delays for its insomnia drug indiplon and a loss of $39.1 million for the third quarter of 2006.
In the latest setback in VaxGen’s efforts to fill a government contract to develop a vaccine for anthrax, the company said that the FDA has placed a planned clinical trial of the product on clinical hold.
Avanir stock fell nearly 46 percent after the company announced it may not continue developing Zenvia after receiving an approvable letter for the drug from the FDA.