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FDA Approves 1st Generic Tamiflu

[ Price : $8.95]

FDA approvea a Nesher Pharmaceuticals ANDA for the first generic version of Genentechs Tamiflu (oseltamivir phosphate) for oral su...

FDA Approves Broader Briviact Use in Epilepsy Patients

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FDA approves a UCB supplemental NDA for Briviact (brivaracetam) as monotherapy for partial-onset (focal) seizures in patients 16 y...

T2 Biosystems Files 510(k) for Sepsis Panel

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T2 Biosystems files a 510(k) for the T2Bacteria Panel that is designed to run on the companys T2Dx Instrument as a rapid diagnosti...

Device Security Should Start in Design: FDA

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CDRH associate director Suzanne Schwartz says medical device manufacturers should build cyber security into their devices at the d...

ICH Genomic Sampling Guidance to be Implemented

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FDA says an ICH guidance on genomic sampling and data has passed Step 4 and is being implemented.

Court Says Essure Suit is Preempted

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Attorney Rachel Weil says a New Your federal court has ruled that a liability suit against Bayer over its Essure birth control dev...

FDA Approves Mvasi Biosimilar of Avastin

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FDA approves Amgens Mvasi, a biosimilar to Genentechs Avastin, for treating multiple forms of cancer.

In Vitro Diagnostic Device Characteristics Guidance

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FDA issues a guidance to facilitate study designs establishing performance characteristics of in vitro diagnostic devices intended...

FDA Approves Expanded COPD Use for Symbicort

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FDA approves AstraZenecas asthma therapy Symbicort (budesonide/formoterol fumarate dihydrate) inhalation aerosol 160/4.5 microgram...

Mobile Medical App Cleared for Substance Use Disorder

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FDA permits under its de novo process the marketing of the first mobile medical application to help treat substance use disorders.