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Progress and Some Concerns in NARMS Report

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FDA releases the 2015 National Antimicrobial Resistance Monitoring System (NARMS) report showing some gains in reducing antibiotic...

FTC Finalizes Abbott/Alere Acquisition Consent Order

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The Federal Trade Commission finalizes a consent order to resolve its concerns about the effect on medical device competition for ...

Baxter Recalls 1 Lot of Nexterone

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Baxter International recalls one lot of Nexterone (amiodarone HCl) 150 mg/100 mL premixed injection due to the potential presence ...

Acorda Phase 3 Parkinsons Study Sees 5 Deaths

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Acorda Therapeutics says a Phase 3 study of tozadenant for Parkinsons disease is linked to five deaths.

Takeda Gout Drug has Higher Cardiovascular Risks: FDA

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An FDA drug safety alert says that Takedas gout drug Uloric (febuxostat) may have an increased risk of heart-related death when co...

Draft Guidance on Biosimilar User Fees

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FDA posts a draft guidance on Assessing User Fees Under the Biosimilar User Fee Amendments of 2017.

FDA Clears Alcyone Lifesciences Alivio System

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FDA clears an Alcyone Lifesciences 510(k) for the Alivio Ventricular Catheter and Flusher System for treating hydrocephalus.

Ultragenyx NDA for Mepsevii OKd for Rare Metabolic Condition

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FDA approves an Ultragenyx Pharmaceutical NDA for Mepsevii (vestronidase alfa-vjbk), the first approved treatment for pediatric an...

FDA Seeking to Improve Hiring Process for New Staff

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FDA commissioner Scott Gottlieb announces a 2018 pilot project to evaluate efforts to make the agency hiring process more efficien...

FDA Authorizes Cancer Tumor Profiling Test

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FDA releases the 2015 National Antimicrobial Resistance Monitoring System (NARMS) report showing some gains in reducing antibiotic...