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Ortho Biotech Submits Trabectedin NDA

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Ortho Biotech submits an NDA to FDA for its trabectedin to be used in combination with Doxil to treat women with relapsed ovarian ...

FDA Corrects Notice on Amprolium Sponsors

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Federal Register Correction: FDA corrects an 8/6 notice designating sponsors of approved applications for oral dosage forms of amp...

Waxman Unseats Dingell on Energy and Commerce Committee

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House Democrats vote to replace long-serving Energy and Commerce Committee chair John Dingell (D-MI) with the committees second-in...

Black Box Warning Needed for Avastin?

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Researchers say it may be appropriate for FDA to add a black box warning on blood clot risk to Avastin labeling.

Sanofi and Barr Settle Patent Suit on Nasacort

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Sanofi-Aventis and Barr Laboratories settle an ongoing patent suit over Barrs ANDA for a generic copy of Nasacort AQ.

FDA Concerned With Drug Heart Risk

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OND director John Jenkins says FDA is re-thinking its approach to clinical trials for drugs used to treat chronic conditions becau...

Obama Selects Former Senator Daschle as HHS Secretary

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President-elect Barak Obama selects former Senate majority leader Tom Daschle as his nominee for Health and Human Services secreta...

Waxman Wins First Round to Unseat Dingell

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Representative Henry Waxman (D-CA) wins a preliminary round to take the chairman seat of the House Energy and Commerce Committee a...

FDA OKs Tevas Generic Pulmicort While Dismissing Petition

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In the face of an ongoing federal court patent suit, FDA approves a Teva Pharmaceutical Industries ANDA for a generic version of A...

Experts Question FDA China Office Success

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FDA opens its three offices in China amid expert concern that they will not be able to do the work expected of them.