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Siemens Healthcare Class 1 Recall of Antibiotic Tests

[ Price : $8.95]

Siemens Healthcare Diagnostics begins a Class 1 recall of its Rapid Neg BP Combo Panel Type 3 and Rapid Neg Urine Combo Panel Type...

Will Drop in CDRH Inspections Continue?

[ Price : $8.95]

Aptiv Solutions says the 2013 drop in medical device facility inspections by CDRH is not likely to continue into future years.

ContraFect Submits Response to Clinical Hold on CF-301

[ Price : $8.95]

ContraFect Corp. submits a response to FDA that it says addresses all of the issues identified in an IND clinical hold letter on C...

Dont Force Pharma to Consult FDA on Trials: LaMattina

[ Price : $8.95]

Former Pfizer executive John LaMattina says drug companies would be wise to consult with FDA on clinical trial protocols, but shou...

FDA OKs Amgen First to Treat Rare Leukemia

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FDA approves Amgens Blincyto, which uses the bodys T-cells to treat patients with relapsed or refractory Philadelphia chromosome-n...

FDA Holds CytRx Aldoxorubicin Trials

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FDA puts a partial clinical hold on all three trials of CytRxs aldoxorubicin for various cancer indications.FDA puts a partial cli...

Puma Delays Expected Filing of NDA for Neratinib

[ Price : $8.95]

Puma Biotechnology says it expects to file an NDA for neratinib for extended adjuvant treatment of HER2-positive early-stage breas...

FDA Clears GI Views Colonoscope System

[ Price : $8.95]

FDA clears a GI View Ltd. 510(k) for its Aer-O-Scope Colonoscope System for colorectal cancer screening.

FDA Approves Sanofis Proftin for Latent TB

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FDA approves a Sanofi supplemental NDA for Priftin (rifapentine) in combination with isoniazid for treating latent tuberculosis in...

1 New, 3 Updated REMS

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FDA approves one new and three updated REMS.