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FDA OKs Suns Generic Fosamax

[ Price : $8.95]

FDA approves a Sun Pharmaceutical Industries ANDA for a generic copy of Mercks Fosamax.

Novacea Scraps Prostate Drug Development

[ Price : $8.95]

Novacea says it has discontinued the development of its androgen-independent prostate cancer drug Asentar after a Phase 3 trial (A...

Gardasil Wins Vulvar/Vaginal Cancer Indications

[ Price : $8.95]

FDA approves two additional indications for Mercks Gardasil vaccine prevention of vaginal and vulvar cancer caused by human papil...

Are FDAs Communications Understood?

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Members of FDAs Risk Communication Advisory Committee say FDA communications may not always be understood by their intended audien...

FDA Opens Docket on LASIK Experience

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Federal Register Notice: FDA opens a public docket to receive information and comments on post-market experience associated LASIK ...

FDA Seeks S&E Data on Ecamsule OTC Use

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Federal Register Notice: FDA requests safety and effectiveness data on the over-the-counter use of Ecamsule (terephthalylidene dic...

FDA OKs Talecris Biotherapeutics Orphan Drug

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FDA approves Talecris Biotherapeutics Gamunex, an immune globulin product indicated for treating chronic inflammatory demyelinatin...

Vanda Responding to FDA on Anti-psychotic

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Vanda Pharmaceuticals will give FDA a complete response to a non-approvable letter on its anti-psychotic iloperiodone.

FDA Clears St. Jude Medicals Confirm ICM

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FDA clears St. Jude Medicals Confirm implantable cardiac monitor.

LifePak Defbrillators Recalled

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CDRH says Physio Control has recalled its LifePak CR automated external defibrillator.