HOME ABOUT US PRINT PUBLICATIONS SUBSCRIPTIONS CONTACT US TELL FRIEND RSS
 
Welcome to FDAweb
Pay Per View
Search our 70,821 - story database FREE
 
Free Items
 Warning Letters
 FDA Notices
 FDA Calendar
 

 FDA Whistleblowers



    








 
 
<< Prev  3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 Next >>
 
TXT Regulatory Review Determined for Daiichi’s Enhertu [104 Words] [ Price : $8.95]
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Daiichi Sankyo’s Enhertu.
11/02/2021
 
 
TXT FDA Approves Novartis’ Scemblix for Some Leukemias [2665 Words] [ Price : $8.95]
FDA approves Novartis’ Scemblix for two distinct chronic myeloid leukemia indications.
11/02/2021
 
 
TXT Breakthrough Designation for Renew Cerezen [2621 Words] [ Price : $8.95]
FDA grants breakthrough device designation to Renew Bioscience’s Cerezen device to treat mild cognitive impairment associated with Alzheimer’s disease.
11/02/2021
 
 
TXT Amylyx Pharmaceuticals NDA for ALS Drug [260 Words] [ Price : $8.95]
Amylyx Pharmaceuticals files an NDA for AMX0035 (sodium phenylbutyrate and taurursodiol), indicated for treating amyotrophic lateral sclerosis.
11/02/2021
 
 
TXT FDA Accepts NDA for Parsaclisib in Lymphomas [200 Words] [ Price : $8.95]
FDA accepts for review an Incyte NDA seeking approval of parsaclisib for treating patients with relapsed or refractory follicular lymphoma, marginal zone lymphoma and mantle cell lymphoma.
11/02/2021
 
 
TXT ANI Pharma sNDA for Purified Cortrophin Gel [162 Words] [ Price : $8.95]
FDA approves an ANI Pharmaceuticals supplemental NDA for purified cortrophin gel (repository corticotropin) for treating certain chronic autoimmune disorders.
11/02/2021
 
 
TXT FDA Withdrawing 18 No-Longer-Marketed NDAs [70 Words] [ Price : $8.95]
Federal Register notice: FDA withdraws approval of 18 NDAs from multiple applicants because the drug products are no longer marketed.
11/01/2021
 
 
TXT Moderna Delaying Pediatric Covid Vaccine EUA Filing [430 Words] [ Price : $8.95]
Moderna says ongoing FDA safety concerns with Moderna’s Covid-19 vaccine and its potential use in adolescents has led to a filing delay for an emergency user authorization for a smaller dose vaccine in the younger pediatric population.
11/01/2021
 
 
TXT Draft Guide on Drug Reporting to FDA [87 Words] [ Price : $8.95]
Federal Register notice: FDA posts a draft guidance entitled Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act.
11/01/2021
 
 
TXT Drug Name Study on Consumer/Doc Interpretations [234 Words] [ Price : $8.95]
Federal Register notice: FDA seeks public comments on a proposed information collection entitled “Text Analysis of Proprietary Drug Name Interpretations.”
11/01/2021
 
 
<< Prev  3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22  Next >>
 

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