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Gilead Files NDA for Remdesivir

[ Price : $8.95]

Gilead Sciences files an NDA for Veklury (remdesivir), indicated for treating patients with Covid-19.

Guide on BIMO Technical Conformance

[ Price : $8.95]

FDA makes available a guidance entitled Bioresearch Monitoring Technical Conformance Guide.

Panel to Discuss Glaxo sNDA for COPD

[ Price : $8.95]

Federal Register notice: FDA announces an 8/31 online Pulmonary-Allergy Drugs Advisory Committee meeting.

Guide on Therapeutic Protein Drug-Drug Interactions

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Drug-Drug Interaction Assessment for Therapeutic Proteins. ...

Guide on NDA/ANDA Marketing Status Notifications

[ Price : $8.95]

FDA makes available a guidance entitled Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic ...

FDA Priority Review for Biogen/Eisai BLA for Alzheimers

[ Price : $8.95]

FDA accepts for priority review a Biogen and Eisai BLA for aducanumab, an investigational treatment for Alzheimers disease.

Draft Guide on Drug Interaction Assessments

[ Price : $8.95]

FDA makes available a draft guidance entitled Drug-Drug Interaction Assessment for Therapeutic Proteins.

Genentechs Spinal Muscular Atrophy Drug Approved

[ Price : $8.95]

FDA approves Genentechs Evrysdi (risdiplam) for treating spinal muscular atrophy in adults and children two months of age and olde...

FDA OKs Joimax Navigation tracking for Spinal Surgery

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FDA clears a Joimax PMA for its Intracs, an electromagnetic navigation tracking and control system for spinal procedures.

AbbVie Pays $24 Million Over Calif. Humira Marketing

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California reaches a settlement agreement with AbbVie Inc. to resolve a lawsuit alleging violations of the California Insurance Fr...