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Pfizer, FDA in talks on prescription details for key breast cancer drug
2015-01-08 18:21:28| Biotech - Topix.net
Pfizer Inc said Thursday it has begun talks with the U.S. Food and Drug Administration to finalize the prescription label of its breast cancer drug palbociclib, in an indication the drug was likely closer to regulatory approval. The largest U.S. drugmaker also said there was no plan for the agency to hold an advisory committee meeting to discuss the medicine prior to an approval decision.
FDA Enforcement Report
2015-01-08 15:45:00| Happi Breaking News
Eye color tests positive for Bacillus cereus.
Tags: report
enforcement
fda
fda report
Fisher Walnuts: Salmonella in FDA Sampling Prompts Recall
2015-01-02 18:50:25| Food - Topix.net
Two Fisher brand walnut products were voluntarily recalled on Wednesday because of salmonella contamination detected during sampling by the U.S. Food and Drug Administration. John B. Sanfilippo & Son, which makes nuts, dried fruits and mixes under the Fisher and Harvest Valley Orchard brands, recalled the Fishers eight-ounce chopped walnuts and its eight-ounce pecan cookie pieces packaged in plastic bags, according to the Chicago Tribune .
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fisher
sampling
prompts
NxStage nabs first-ever FDA approval for overnight home hemodialysis
2014-12-29 22:34:30| Biotech - Topix.net
The Lawrence medical device company that virtually invented the market for home-based hemodialysis treatment, NxStage Medical, last week earned the first approval to be used overnight while the patient is at home sleeping.
Tags: home
approval
overnight
fda
PTC Therapeutics Begins Rolling NDA Submission To The FDA For Translarna To Treat Duchenne Muscular Dystrophy
2014-12-29 01:59:52| drugdiscoveryonline Home Page
PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that it has commenced a rolling submission of a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for Translarna™ for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD)
Tags: treat
begins
rolling
submission
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