Tag: FDA approval
Allergan Seeks Broader FDA Approval for Weight-Loss Implant
by Melly Alazraki on Dec.01, 2010, under Towing
Allergan’s Lap-Band, a device implanted in the stomach to limit the amount of food that can be ingested, is already on the market to help the very obese lose weight. But now the company hopes to win approval for less obese patients to use the band.
Continue reading Allergan Seeks Broader FDA Approval for Weight-Loss Implant
Allergan Seeks Broader FDA Approval for Weight-Loss Implant originally appeared on DailyFinance on Wed, 01 Dec 2010 20:45:00.
Filed Under: Health Care
Amgen’s Denosumab Approved for Cancer Patients
by Melly Alazraki on Nov.19, 2010, under Towing
The FDA has approved Amgen’s osteoporosis drug denosumab for use by cancer patients with solid tumors whose disease has metastasized to their bones. The indication to prevent complications such as fractures and bone pain among those patients could boost the drug’s sales by billions.
Continue reading Amgen’s Denosumab Approved for Cancer Patients
Amgen’s Denosumab Approved for Cancer Patients originally appeared on DailyFinance on Fri, 19 Nov 2010 13:24:00.
Filed Under: Company News, Health Care, Novartis, Amgen, Stocks in the News
How to Approve ‘Biosimilar’ Drugs? The FDA Has to Figure That Out
by Melly Alazraki on Nov.03, 2010, under Towing
Unlike generics, which are the exact chemical copies of a brand-name drug, biosimilars have large and often complex proteins that are made in living cells, and tiny differences can play havoc with the product. It may take years for the FDA to create an approval process.
Continue reading How to Approve ‘Biosimilar’ Drugs? The FDA Has to Figure That Out
How to Approve ‘Biosimilar’ Drugs? The FDA Has to Figure That Out originally appeared on DailyFinance on Wed, 03 Nov 2010 17:20:00.
Filed Under: Health Care, Johnson & Johnson, Pfizer, Merck, Amgen
Pfizer Makes Headway in the Fight Against Lung Cancer
by Melly Alazraki on Oct.28, 2010, under Towing
Pfizer’s cancer drug crizotinib was able to shrink tumors of non-small-cell lung cancer patients whose tumors carried a specific genetic mutation that fuses two genes. The early-stage study results were published in the New England Journal of Medicine.
Continue reading Pfizer Makes Headway in the Fight Against Lung Cancer
Pfizer Makes Headway in the Fight Against Lung Cancer originally appeared on DailyFinance on Thu, 28 Oct 2010 17:30:00.
Filed Under: Company News, Health Care, Pfizer, Stocks in the News
Lilly, Amylin, Alkermes Shares Get Crushed After FDA Rejects Diabetes Drug
by Melly Alazraki on Oct.20, 2010, under Towing
Shares of pharmaceutical companies Amylin, Alkermes, and Eli Lilly — partners in a new diabetes drug Bydureon — have tanked in morning trading as the U.S. Food and Drug Administration declined on Tuesday to approve the drug without additional clinical studies.
Continue reading Lilly, Amylin, Alkermes Shares Get Crushed After FDA Rejects Diabetes Drug
Lilly, Amylin, Alkermes Shares Get Crushed After FDA Rejects Diabetes Drug originally appeared on DailyFinance on Wed, 20 Oct 2010 10:40:00.
Filed Under: Company News, Health Care, GlaxoSmithKline, Eli Lilly, Stocks in the News
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