Regulatory Affairs Syndicator

Researchers are seeking participants for the first U.S. study of the safety of a new vaginal gel designed to prevent herpes and HIV infection.
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Cyndy King, PhD, NP, FAAN New Hampshire is the first state to announce plans to offer the new cervical-cancer vaccine free to all girls.
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Pregnant women and those who plan to become pregnant should avoid taking the antidepressant Paxil if possible because of the risk of birth defects, a group of obstetricians said Thursday.
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With a new report blaming drug-coated heart stents for a fivefold increase in the risk of clotting problems and a Food and Drug Administration panel poised to investigate the devices next week, hospitals that …
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Progen Industries today announced it has received notification from the U.S. FDA that the appropriate CMC procedures have been put in place to progress its anti-cancer drug PI-88 to Phase III clinical trials.
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Shares of Possis Medical Inc. jumped more than 9 percent Wednesday after the medical-device company received government clearance to market a catheter for its AngioJet product - used to clear blood clots - as a …
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Japan is the highest per capita user of Tamiflu, which until recently posted very sluggish sales in North America.The advisory comes more than two weeks after the U.S. Food and Drug Administration warned …
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New Hampshire announced plans Wednesday to become the first state to offer the new cervical-cancer vaccine free to all girls.
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CONCORD, N.H. New Hampshire will become the first state to offer a new cervical-cancer vaccine free to all girls.
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A U.S. Food and Drug Administration advisory panel recommended Wednesday that use of the painkiller Celebrex be expanded to treat children with juvenile rheumatoid arthritis .
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Blood clotting is four to five times more likely in patients getting drug-coated heart devices known as stents, compared to the older bare-metal variety, according to a large data analysis released Wednesday.
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Barr Pharmaceuticals Inc , a specialty pharmaceutical company, reported on 28 November that its subsidiary PLIVA d.d. has received final approval from the US Food and Drug Administration for its Abbreviated …
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Key points: - Receives green light from the Food and Drug Administration to manufacture PI-88 for upcoming Phase III trial - Manufacturing in-house saves Progen approximately AUD$7.8 m in outsourcing fees - …
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Uroplasty, Inc. and CL Medical of Lyon, France announced that CL Medical has received a 510 premarket clearance from the U.S. Food and Drug Administration for its I-Stop TOMS sling for treatment of male stress …
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A federal trial over the right to sell a multi-billion-dollar cardiovascular drug has begun.
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