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Lupron sNDA Approved for Long-term Data

[ Price : $8.95]

FDA approves an Abbott supplemental NDA for Lupron Depot-PED (leuprolide acetate for depot suspension) to include long-term data i...

FDA Reports Big Increase in Botanical INDs

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CDER says it is experiencing a big increase in the number of INDs it is receiving for botanical drugs compared with eight years ag...

FDA Not Pursuing Suspect Chinese Heparin Firms: Lawmakers

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Republican House Energy and Commerce Committee leaders ask FDA to explain why it apparently continues to allow two Chinese compani...

Stealth Therapeutics Invisiport Cleared

[ Price : $8.95]

FDA clears a Stealth Therapeutics 510(k) for its Invisiport, an alternative to traditional chest ports and peripherally inserted c...

FDA Reportedly Backs Adventrx Docetaxel Trial

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FDA says a proposed single clinical study would generate sufficient data to support approval of Adventrx Pharmaceuticals docetaxel...

FDA Expanding Power Over Intrastate Commerce

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Attorneys William Koustas and John Fleder caution regulated industry to protest FDA attempts to regulate products that do not trav...

FDA Panel Backs Atricure PMA for Afib Ablation Device

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FDA's Circulatory System Devices Panel votes to recommend approval of an AtriCure PMA for its Synergy Ablation device and its use ...

FDA Clears Vapotherm Heliox Device

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FDA clears a Vapotherm 510(k) for the Precision Flow Heliox, a high-flow humidification system designed for use with blended heliu...

Final Birth Control Blood Clot Report Backs Concerns

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FDA says that results of a study it funded confirm an association between some birth control pills and increased risk of blood clo...

FDA OKs Mylan's Generic MS Contin

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FDA approves a Mylan Pharmaceuticals ANDA for a generic version of Purdue Pharma's MS Contin.