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Gilead Recalls Veklury Over Glass Particle

[ Price : $8.95]

Gilead Sciences recalls one lot of Veklury (remdesivir) for injection 100 mg/vial, after it received a customer complaint about th...

FDA Taps Industry Vet as Device Evaluation Chief

[ Price : $8.95]

FDA has appointed industry veteran and consultant Ross Segan as CDRH Office of Product Evaluation and Quality director, replacing ...

Ideaya Bio Plans Phase 3 for Darovasertib

[ Price : $8.95]

Ideaya Biosciences says it is advancing darovasertib into a Phase 3 trial following positive interim Phase 2 clinical trial data o...

3 Guides on Device Conformity Assessment Program

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Federal Register notice: FDA makes available three draft guidances for its Accreditation Scheme for Conformity Assessment Program.

Guide on Device Biocompatibility Assessments

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Federal Register notice: FDA makes available a draft guidance entitled Chemical Analysis for Biocompatibility Assessment of Medica...

FDA OKs 3 New Indications for Bimzelx

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FDA approves UCBs Bimzelx (bimekizumab-bkzx) for treating adults with active psoriatic arthritis, active non-radiographic axial sp...

Zevras Niemann-Pick Disease Drug Approved

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FDA approves Zevra Therapeutics Miplyffa (arimoclomol) for treating Niemann-Pick disease, Type C (NPC) in adults and children aged...

CMC Development and Readiness Pilot

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Federal Register notice: FDA announces year three of its Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pi...

3 FDA Guides on Device Accreditation Scheme for Conformity

[ Price : $8.95]

FDA posts three medical device-related draft guidances about the agencys Accreditation Scheme for Conformity Assessment Program.

Sanofis Sarclisa OKd for Multiple Myeloma

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FDA approves a Sanofi-Aventis supplemental BLA for Sarclisa (isatuximab-irfc) for use with bortezomib, lenalidomide, and dexametha...