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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

[ Price : $8.95]

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

Guide on Device Biocompatibility Assessments

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Chemical Analysis for Biocompatibility Assessment of Medica...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

9 No-Longer-Marketed ANDAs Withdrawn

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Federal Register notice: FDA withdraws approval of nine no-longer-marketed ANDAs from multiple applicants.

Adverse Event Reporting Info Collection Revised

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Federal Register notice: FDA seeks comments on an information collection revision entitled Postmarketing Adverse Experience Report...

Smiths Recalls ParaPAC Ventilators

[ Price : $8.95]

Smiths Medical recalls (Class 1) its ParaPAC plus P300 and P310 ventilators due to the possibility that patient outlet connectors ...

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...