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Vertex Pharmas Kalydeco Gains Expanded Indication

[ Price : $8.95]

FDA approves Vertex Pharmaceuticals Kalydeco (ivacaftor) for use in certain children with cystic fibrosis ages four months to less...

FDA OKs Glaxos Nucala for Hypereosinophilic Syndrome

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FDA approves GlaxoSmithKlines Nucala (mepolizumab) for adults and children aged 12 years and older with hypereosinophilic syndrome...

RemeGen Breakthrough Status for Disitamab Vedotin

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FDA grants RemeGen a Breakthrough Therapy designation for disitamab vedotin (RC48), an anti-HER2 antibody drug conjugate for secon...

3 Device Accreditation Guidances Issued

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FDA publishes three guidances implementing the voluntary pilot for the Accreditation Scheme for Conformity Assessment.

House Hearing on Unsustainable Drug Prices

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The House Oversight and Reform Committee schedules two days of hearings on drug prices with testimony from executives of six compa...

Proposal to Withdraw 5 ANDAs for Lack of REMS

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Federal Register notice: FDA proposes to withdraw approval of five ANDAs because the application holders have repeatedly failed to...

Trump May Not Back New FDA Vaccine Guidance

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After FDA commissioner Stephen Hahn assured Congress that FDAs review and approval/authorization of a Covid-19 vaccine would be ba...

3 Observations in Front Range Laboratory Inspection

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FDA releases the FDA-483 with three observations from an inspection at Front Range Laboratories.

Webinar on Drug QT/Proarrhythmic Risk Assessments

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FDA announces a two-day (10/15-16) public Webinar on New Approaches for an Integrated Nonclinical-Clinical QT/Proarrhythmic Risk A...

High-Risk Groups Should Avoid Amalgam Fillings: FDA

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FDA says it now recommends that people in seven high-risk categories refrain from exposure to dental mercury amalgam when possible...