FDA Related News

Biologics

FDA Priority Review for Biogen/Eisai BLA for Alzheimers

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

Human Drugs

Draft Guide on Drug Interaction Assessments

FDA makes available a draft guidance entitled Drug-Drug Interaction Assessment for Therapeutic Proteins.

Human Drugs

Genentechs Spinal Muscular Atrophy Drug Approved

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

Medical Devices

FDA OKs Joimax Navigation tracking for Spinal Surgery

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

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

Human Drugs

FDA OKs Dovato for Replacement HIV Regimen

FDA approves ViiV Healthcares Dovato (dolutegravir/lamivudine) for treating HIV-1 infection to replace the current three-drug antiretroviral regimen i...

Human Drugs

Majority of PMRs/PMCs On Schedule: Report

FDA says a majority of postmarketing requirements and commitments are completed or moving toward completion on schedule.

Federal Register

Annual Report on Postmarketing Requirements/Commitments

Federal Register notice: FDA makes available an annual report entitled Report on the Performance of Drug and Biologics Firms in Conducting Postmarketi...

Federal Register

Final Guide on Limited Population Pathway

Federal Register notice: FDA makes available a final guidance entitled Limited Population Pathway for Antibacterial and Antifungal Drugs.

Human Drugs

Rare Disease Clinical Trial Resource Center Proposed

The Rare Diseases Clinical Research Network says FDA should consider creating a Rare Diseases Clinical Trial Resource Center as a resource for existin...