Topic: Food and Drug Administration
(Reuters) - U.S. regulators have extended their review of Biogen Idec Inc's application to update the prescribing information for its multiple sclerosis drug Tysabri, the company said on Thursday.Biogen, which sells the drug with Irish drugmaker Elan Corp Plc, is seeking to ...
US health officials Wednesday announced approval of the first new drug in 56 years to treat lupus, a potentially fatal autoimmune disease affecting millions worldwide.The US Food and Drug Administration said it approved belimumab, marketed under the trade name Benlysta, an inhibitor ...
WASHINGTON (Reuters) - The first new treatment in a half-century for the autoimmune disease lupus won U.S. approval on Wednesday. The drug, Benlysta from Human Genome Sciences Inc, is given once a month by intravenous infusion.Below are some facts about lupus, current ...
WASHINGTON (Reuters) - Human Genome Sciences Inc's lupus drug is poised to win clearance this week, offering patients the first approved treatment option in a half-century and setting the company up for blockbuster sales.Industry analysts widely expect Benlysta, one the most closely ...
WASHINGTON (Reuters) - Human Genome Sciences Inc's lupus drug is poised to win U.S. clearance this week, offering patients the first approved treatment option in a half-century and setting the company up for blockbuster sales.Industry analysts widely expect Benlysta, one the most ...
Merck KGaA announced today that the U.S. Food and Drug Administration (FDA) has extended its review period for Cladribine Tablets as a therapy for relapsing forms of multiple sclerosis (MS) by three months to February 28, 2011.. Merck Serono's oral formulation of ...
A few days before the independent FDA committee review of Human Genome Sciences' (HGSI) systemic lupus erythematosus (SLE) drug Benlysta (belimumab), the FDA suggested that the drug has marginal efficacy and scary adverse effects. The FDA message to the independent committee, which ...
Experimental lupus drug Benlysta - co-developed by Human Genome Sciences and GlaxoSmithKline - moved one step closer to approval yesterday. An FDA advisory panel voted to recommend approval by a sizeable margin: As we've so often said, the FDA doesn't have to ...
U.S. Food and Drug Administration advisers voted 13-2 Tuesday to recommend approval of the first new drug in more than 50 years to treat the autoimmune disease lupus.. In a report submitted to the advisory committee before the vote, the FDA had ...
At the end of a day of often emotional testimony, an FDA advisory panel overwhelmingly voted to recommend the approval of a new drug for the treatment of systemic lupus.. ?It has a weak effect, but they made the case,? panelist Matthew ...
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Dr. Mercola Discusses the FDA
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