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FDA Approves Lillys Cyramza for Lung Cancer

[ Price : $8.95]

FDA approves an Eli Lilly supplemental NDA to expand the approved use of Cyramza (ramucirumab) to treat patients with metastatic n...

ChemoCentryx Positive Phase 2 Data with Diabetic Nephropathy

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ChemoCentryx says a 52-week Phase 2 clinical trial involving its orally administered C-C chemokine receptor 2 antagonist CCX140 in...

FDA OKs MP Biomedicals HTLV Test

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FDA grants approval to MP Biomedicals for its MP Diagnostics Human T-Cell Lymphotropic Virus Blot 2.4, a Western Blot for HTLV con...

FDA Approves Medtronic Left Ventricular Leads

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FDA approves a Medtronic PMA for two additional Attain Performa left ventricular quadripolar leads, which can be paired with the M...

Pfizerpen Not Withdrawn for S&E

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Federal Register Notice: FDA determines that Pfizerpen Pfizerpen (penicillin G potassium) Injection, 1 million units/vial was not ...

Guidance on BE Studies for Budesonide ER Tablets

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Federal Register Notice: FDA releases a draft guidance: Bioequivalence Recommendations for Budesonide Extended-Release Tablets.

FDA Accepts ArmaGen IND Hunter Syndrome Therapy

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FDA accepts an ArmaGen, Inc. IND application for its AGT-182 for treating Hunter syndrome.

FDA OKs WaterWear for Cochlear Implant Processor

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FDA approves Med-El USAs WaterWear submergible waterproof cover for the Rondo Cochlear Implant Audio Processor.

Ex-FDA Chief of Staff Moves to DC Law Firm

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Former FDA chief of staff Lisa Barclay joins the law firm Boies, Schiller & Flexner as counsel in its Washington, DC, office.

FDA Guidance on Safety of Implants Near Magnetic Resonance

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FDA releases a final guidance on Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance Environment.