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FDA Orphan Drug Status for BiovaxID

[ Price : $8.95]

FDA grants Biovest International an orphan drug designation for BiovaxID for treating Waldenstrom's macroglobulinemia.

Gilead NDA for Quad in Treating HIV

[ Price : $8.95]

Gilead Sciences files an NDA for Quad, a single-tablet regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil...

FDA Narrows Data Integrity Concern at CRO

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FDA says fewer NDA/ANDA bioanalytical studies will need to be repeated or confirmed based on earlier data integrity concerns at co...

Lupron sNDA Approved for Long-term Data

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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

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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 ...