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FDA OKs St. Jude Medical TactCath Quartz Ablation Catheter

[ Price : $8.95]

FDA approves a St. Jude Medical PMA for its TactiCath Quartz irrigated ablation catheter, a real-time objective measure of the for...

Baxter Recalls 2 Intravia Container Lots

[ Price : $8.95]

Baxter International recalls two lots of Intravia containers in the U.S. and Canada due to complaints about particulate matter fou...

Group Challenges FDA on Animal Data Reliance

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The Center for Responsible Science says FDA should refine its recently released Draft Informed Consent Information Sheet: Guidance...

Pfizer Walks Away From Remoxy Development

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Pfizer tells its development partner Pain Therapeutics that it has decided to discontinue its agreement to develop and commerciali...

FDA Grants MediciNova Orphan Status for IPF Drug

[ Price : $8.95]

FDA grants MediciNova an orphan-drug designation for MN-001 (tipelukast) for treating idiopathic pulmonary fibrosis.

Rich Pharma Submits IND to FDA for Blood Diseases

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Rich Pharmaceuticals submits an IND application to FDA for a Phase 2 clinical trial of its RP-323 in patients with acute myelocyti...

CBER Guide on Same Surgical Procedure Under HCT/P Rule

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A new CBER draft guidance outlines certain exemptions for procedures involving human cells, tissues or cellular or tissue-based pr...

FDA Approves Baxter BLA for Acquired Hemophilia A Therapy

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FDA approves a Baxter Healthcare BLA for Obizur [antihemophilic factor (recombinant), porcine sequence] for treating bleeding epis...

FDA Warning Letter on Hikma Pharmas Portugal Plant

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FDA issues a Warning Letter to Hikma Pharmaceuticals, citing GMP issues related to environmental monitoring at its plant in Portug...

Dallas Jury Clears J&J Unit in Hip Implant Case

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A Dallas jury finds that Johnson & Johnsons DePuy unit did not market defective metal-on-metal hip implants.