German Schering: FDA grants priority review for Bonefos
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LONDON (CBS.MW) -- German drugmaker Schering AG (DE:717200) (SHR) said the Food and Drug Administration has granted a priority review for Bonefos.
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Genzyme Corp. of Cambridge and German partner Bayer Schering Pharma AG said they have begun phase 3 trials of their cancer drug Campath to treat multiple sclerosis. The companies said they plan on reporting phase 2 results Oct. 14. After phase 3, they hope to seek US regulatory approval in 2011 to market the drug, also known as alemtuzumab, to ...
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MADISON, NJ - Pharmaceutical firm Wyeth said Tuesday that the Food and Drug Administration (news - web sites) granted fast-track status to its experimental cancer drug temsirolimus as an initial treatment for patients with advanced kidney cancer.
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German drug maker Schering, recently acquired by pharmaceuticals and chemicals giant Bayer, has said that it was teaming up with British drug giant AstraZeneca to develop a new treatment against breast cancer.
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Osteoporosis drug could give the company its next big winner.
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The U.S. Food and Drug Administration on Thursday ordered the review of preventative studies involving Pfizer Inc.'s painkillers Celebrex and Bextra, in light of recent evidence they may increase the risk of heart attack and stroke.
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Cancer drug shows exceptional promise as it moves toward FDA review.
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Inhibitex Inc. stood out from a mixed biotechnology sector Monday, jumping more than 20 percent on news that it will receive a fast-tracked review for a staph-infection treatment.
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Nov. 5, 2004 -- FDA officials announced Friday that they will launch a review of the agency&#39;s drug monitoring policies in the wake of recent high-profile safety concerns about widely used drugs, including antidepressants and Vioxx.
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The drugmaker signed a deal to authorize a generic form of its osteoporosis drug Fosamax, which has annual sales of $3 billion, making it the worldâs top-selling drug for osteoporosis.
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NEW YORK  - U.S. regulators will review Isentress, an investigational drug for HIV infection, on a priority basis, and a decision is anticipated by mid-October, Merck & Co. said on Wednesday.
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U.S. regulators said on Friday they  would review whether to take action over Merck & Co Inc's   and Schering-Plough Corp's  popular cholesterol  medicine Vytorin after a study showed it was no better than a  generic drug in preventing the build-up of fatty plaque.
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Roche Holding AG and GlaxoSmithKline said on Wednesday they asked U.S. regulators to approve an intravenous form of their osteoporosis drug that could be administered far less frequently.
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Eyetech Pharmaceuticals (EYET:Nasdaq - news - research) faces an important regulatory test Aug. 27 when a Food and Drug Administration advisory panel will review Macugen, the company&#39;s experimental drug intended
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Shares of Oragenics Inc. jumped after the biotechnology company reported Tuesday that the Food and Drug Administration allowed it to proceed with safety trials on a lifelong tooth decay protection rinse that
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Procter &amp; Gamble Pharmaceuticals said Tuesday the Food and Drug Administration granted the company priority review status for its Intrinsa female testosterone patch.
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Shares in Schering dropped on Friday  after the German drugmaker said U.S. regulators needed more  information to approve its key Bonefos drug for use in  preventing bone tumors in breast cancer patients.