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FDA Grants Seattle Genetics Breakthrough Status for Adcetris

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FDA grants Seattle Genetics a breakthrough therapy designation for Adcetris (brentuximab vedotin) for treating patients with CD30-...

Retrophin Gains FDA Agreement on Retrophin Phase 3 Trial

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Retrophin reaches an agreement with FDA under a Special Protocol Assessment for a Phase 3 clinical trial evaluating RE-024, an in...

Trump Transition Healthcare Team Shapes Up

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President-elect Donald Trump reportedly selected former HHS official Andrew Bremberg to lead the transition team for HHS.

Device Firm Pays $36 Million Over Misbranding Charges

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Pennsylvania-based medical device manufacturer Biocompatibles pleads guilty to misbranding its embolic device LC Bead and will pay...

FDA Approves Gileads new Hepatitis B Therapy

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FDA approves a Gilead Sciences NDA for Vemlidy (tenofovir alafenamide, TAF) 25mg, a once-daily treatment for adults with chronic h...

No Major Changes at FDA: Pines

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Former FDAer Wayne Pines outlines three impacts of the election results on FDA in the future.

OIG Work Plan Has 5 Drug, Device Activities

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The HHS Inspector General releases a 2017 work plan with five items relating to FDA oversight of drugs and medical devices.

Virtus Pharmaceuticals Petition Denied on Procedural Grounds

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FDA denies on procedural grounds a Virtus Pharmaceutical petition asking it to investigate whether two producers of potassium chlo...

Americans Oppose Off-label Promotion: Consumer Reports

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Consumer Reports shares with FDA results from a new poll showing that most Americans (84%) do not want companies to be allowed to ...

21st Century Cures Bill a Disaster Still: Yale Critic

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Yale Universitys Collaboration for Research Integrity and Transparency renews its sharp criticism of the pending 21st Century Cure...