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Orphan Status for GT Biologics Pediatric Crohns Therapy

[ Price : $8.95]

FDA grants GT Biologics an orphan drug designation for Thetanix (bacteroides thetaiotaomicron) for treating pediatric Crohns disea...

FDA, Cell Therapeutics Agree on Special Protocol

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FDA and Cell Therapeutics reach agreement on a Special Protocol Assessment for a planned pivotal Phase 3 clinical trial known as t...

CEL-SCI Signs with U.S. Navy for Multikine Study

[ Price : $8.95]

CEL-SCI Corp. signs a research agreement with the U.S. Naval Medical Center in San Diego to conduct a Phase 1 study of Multikine i...

Baxter Clinolipid Approved for Parenteral Nutrition

[ Price : $8.95]

FDA approves a Baxter healthcare NDA for Clinolipid (lipid injectable emulsion, USP) for intravenous feeding (parenteral nutrition...

Roche Begins Study in Leukemia, Myelodysplastic Syndrome

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Roche and Genentech begin a Phase 1b/2 study of Erivedge in patients with relapsed/ refractory acute myelogenous leukemia and rela...

FDA Approves New Specs for Discoverys Surfaxin

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FDA approves Discovery Laboratories updated product specifications for Surfaxin (lucinactant) Intratracheal Suspension, indicated ...

FDA Favoring CardioMEMS PMA for Heart Monitor

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FDA appears to be supporting approval of a CardioMEMS PMA for its Champion HF Monitoring System, an implantable pressure measureme...

Budget Impasse Should Not Affect Ongoing Product Reviews: FDA

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FDA says the ongoing budget impasse and partial government shutdown should not affect its routine product review process for drug ...

Ben Venue Shuttering GMP-Plagued Ohio Facility

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Ben Venue Laboratories says the cost of complying with GMPs at its troubled Bedford, OH manufacturing facility has led it to cease...

FDA Grants Cornerstone Pharma Orphan Drug Status

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FDA grants Cornerstone Pharmaceuticals an orphan drug designation for CPI-613, its lead altered energy metabolism-directed drug ca...