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Carefusion Class 1 Recall of Ventilator

[ Price : $8.95]

CareFusion recalls its EnVe Ventilator after identifying potential defects that can interrupt ventilation to patients.

Genentech FDA-483 Cites Avastin Manufacturing Deficiencies

[ Price : $8.95]

A September FDA inspection of a Genentech facility cites the firm for deficiencies related to Avastin's manufacturing.

RegeneRx Plans Meeting with FDA on Dry Eye Drug

[ Price : $8.95]

RegeneRx Biopharmaceuticals says it plans to confirm with FDA outcome measures for an upcoming Phase 3 study involving its dry eye...

FDA 'Smoke & Mirrors' Report Shows Record Approvals

[ Price : $8.95]

A new FDA report uses some smoke and mirrors to accentuate its approval record for last fiscal year.

CVM Corrects Erroneous Antimicrobials Sales Report

[ Price : $8.95]

CVM replaces an incomplete summary report on antimicrobials sold or distributed last year for use in food-producing animals.

Comments Sought on Device Mfr. Electronic Submissions

[ Price : $8.95]

Federal Register Notice: FDA seeks comments on the agency requirement that device establishments submit registration and listing i...

FDA Accepts Qnexa NDA for Obesity

[ Price : $8.95]

FDA accepts for review a Vivus NDA resubmission for Qnexa to treat obesity.

Abbott Sues Perrigo Over Androgel Patent Infringement

[ Price : $8.95]

Abbott sues Perrigo for Androgel patent infringement after Perrigo files an NDA for testosterone gel 1%.

Glaxo to Pay $3 Billion to Settle Marketing Probes

[ Price : $8.95]

GlaxoSmithKline expects to finalize a $3 billion settlement with the federal government in 2012 to resolve a number of outstanding...

Researcher Criticizes FDA Chantix Studies, Conclusions

[ Price : $8.95]

Researchers say that Pfizers Chantix has too many neuropsychiatric risks to be used as a first-line smoking cessation treatment.