HOME ABOUT US PRINT PUBLICATIONS SUBSCRIPTIONS CONTACT US TELL FRIEND RSS
 
Welcome to FDAweb
Pay Per View
Search our 67,621 - story database FREE
 
Free Items
 Warning Letters
 FDA Notices
 FDA Calendar
 

 FDA Whistleblowers



    








 
 
  1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Next >>
 
TXT FDA Priority Review for Biogen/Eisai BLA for Alzheimer’s [210 Words] [ Price : $8.95]
FDA accepts for priority review a Biogen and Eisai BLA for aducanumab, an investigational treatment for Alzheimer’s disease.
08/07/2020
 
 
TXT Draft Guide on Drug Interaction Assessments [146 Words] [ Price : $8.95]
FDA makes available a draft guidance entitled “Drug-Drug Interaction Assessment for Therapeutic Proteins.”
08/07/2020
 
 
TXT Genentech’s Spinal Muscular Atrophy Drug Approved [215 Words] [ Price : $8.95]
FDA approves Genentech’s Evrysdi (risdiplam) for treating spinal muscular atrophy in adults and children two months of age and older.
08/07/2020
 
 
TXT FDA OK’s Joimax Navigation tracking for Spinal Surgery [161 Words] [ Price : $8.95]
FDA clears a Joimax PMA for its Intracs, an electromagnetic navigation tracking and control system for spinal procedures.
08/07/2020
 
 
TXT AbbVie Pays $24 Million Over Calif. Humira Marketing [249 Words] [ Price : $8.95]
California reaches a settlement agreement with AbbVie Inc. to resolve a lawsuit alleging violations of the California Insurance Frauds Prevention Act involving the marketing of Humira (adalimumab).
08/07/2020
 
 
TXT FDA OK’s Dovato for Replacement HIV Regimen [225 Words] [ Price : $8.95]
FDA approves ViiV Healthcare’s Dovato (dolutegravir/lamivudine) for treating HIV-1 infection to replace the current three-drug antiretroviral regimen in adults with no known resistance to the two individual components of Dovato.
08/07/2020
 
 
TXT Majority of PMRs/PMCs On Schedule: Report [2636 Words] [ Price : $8.95]
FDA says a majority of postmarketing requirements and commitments are completed or moving toward completion on schedule.
08/06/2020
 
 
TXT Annual Report on Postmarketing Requirements/Commitments [62 Words] [ Price : $8.95]
Federal Register notice: FDA makes available an annual report entitled “Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments.”
08/06/2020
 
 
TXT Final Guide on Limited Population Pathway [73 Words] [ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled “Limited Population Pathway for Antibacterial and Antifungal Drugs.”
08/06/2020
 
 
TXT Rare Disease Clinical Trial Resource Center Proposed [2721 Words] [ Price : $8.95]
The Rare Diseases Clinical Research Network says FDA should consider creating a Rare Diseases Clinical Trial Resource Center as a resource for existing rare disease networks.
08/06/2020
 
 
  1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20  Next >>
 

FERDIC INCORPORATED - P.O. Box 28, Camp Hill, PA 17001 | Phone: (717)731-1426 fax:(717)731-1427 Email: info@fdaweb.com