HOME ABOUT US PRINT PUBLICATIONS SUBSCRIPTIONS CONTACT US TELL FRIEND RSS
 
Welcome to FDAweb
Pay Per View
Search our 70,551 - 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 ChemoCentryx Vasculitis Drug Approved [215 Words] [ Price : $8.95]
FDA approves a ChemoCentryx NDA for Tavneos (avacopan) as an add-on treatment for adult patients with severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis in combination with standard therapy.
10/08/2021
 
 
TXT Panel Unanimously Backs Takeda Cytomegalovirus Drug [149 Words] [ Price : $8.95]
FDA’s Antimicrobial Drugs Advisory Committee votes 17-0 to recommend approval of Takeda’s maribavir to treat cytomegalovirus infection in the post-transplant setting.
10/08/2021
 
 
TXT Labeling Recommendations for Surgical Staplers [59 Words] [ Price : $8.95]
Federal Register notice: FDA announces a final guidance entitled Surgical Staplers and Staples for Internal Use — Labeling Recommendations.
10/08/2021
 
 
TXT Surgical Staplers Up-classified to Class 2 [164 Words] [ Price : $8.95]
Federal Register notice: FDA issues a final order to reclassify surgical staplers for internal use from Class 1 into Class 2 and subject to premarket review.
10/08/2021
 
 
TXT FDA Outlines Novel Excipient Pilot Program [266 Words] [ Price : $8.95]
FDA outlines a new pilot program on using novel excipients with the intent to increase their use in drug development, especially if they have potential public health benefits.
10/08/2021
 
 
TXT Janssen Stelara Juvenile Psoriatic Arthritis sBLA [202 Words] [ Price : $8.95]
Janssen Pharmaceutical files a supplemental BLA for Stelara (ustekinumab) for treating pediatric patients aged five years and older with juvenile psoriatic arthritis.
10/08/2021
 
 
TXT Genentech ‘Breakthrough’ Status on Alzheimer’s Drug [208 Words] [ Price : $8.95]
FDA grants Genentech a breakthrough therapy designation for gantenerumab, an anti-amyloid beta antibody developed for subcutaneous administration in Alzheimer’s disease patients.
10/08/2021
 
 
TXT Warning on Needle-free Devices for Dermal Fillers [187 Words] [ Price : $8.95]
FDA issues a warning to health care professionals to not use needle-free devices such as hyaluron pens for injecting hyaluronic acid or other lip and facial fillers.
10/08/2021
 
 
TXT FDA Reclassifies Surgical Staplers, Staples [2948 Words] [ Price : $8.95]
FDA reclassifies surgical staplers for internal use from Class 1 to Class 2 and delays enforcement of the change for 180 days.
10/07/2021
 
 
TXT De Novo Sought for Fibromyalgia Neuromodulator [200 Words] [ Price : $8.95]
NeuroMetrix submits a de novo request for its Quell wearable neuromodulation device for treating symptoms of fibromyalgia in adults.
10/07/2021
 
 
  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