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FDA OKs Genentechs Avastin for Ovarian/Fallopian Tube Cancers

[ Price : $8.95]

FDA approves Genentechs Avastin (bevacizumab), either in combination with carboplatin and paclitaxel or in combination with carbop...

Former FDA Official Outlines Needed Improvements at Agency

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A former FDA official calls out the agency over a couple of recent approvals that defy common sense and lack scientific proof that...

ICD Protocol, Implementation Weaknesses: Study

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Researchers say they found that current ICDs are vulnerable to computer attacks that could compromise patient safety.

CGMP Deviations Found in Spains Interquim

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FDA warns Spains Interquim about CGMP deviations in its manufacturing of active pharmaceutical ingredients.

Comments Extended on Abuse-deterrent Properties for Opioids

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Federal Register Notice: FDA extends the comment period related to its public meeting on Pre-Market Evaluation of Abuse-Deterrent ...

CDER New Drugs Director Jenkins to Retire

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After almost 25 years at FDA, CDER Office on New Drugs director John Jenkins announces his retirement.

Comments Sought on Device Pediatric Use Information

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Federal Register Notice: FDA seeks comments on an information collection extension request related to a guidance on Providing Info...

Guidance on Clin Pharm Labeling for Drugs

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Federal Register Notice: FDA makes available a guidance entitled Clinical Pharmacology Section of Labeling for Human Prescription ...

FDA Clears Kyocera Medical Total Hip System

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Kyocera Medical Corp. receives 510(k) clearance for its Initia Total Hip System which features Bioceram Azul (blue) zirconia-tough...

Kite Pharma Begins BLA for CAR-T Cell Therapy

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Kite Pharma begins a rolling BLA submission for KTE-C19 (axicabtagene ciloleucel) as a treatment for patients with relapsed/refrac...