Blog
RSS FeedPosted by Michael Wonder on 20 May 2022
AbbVie submits new drug application to U.S. FDA for investigational ABBV-951 (foscarbidopa/foslevodopa) for the treatment of advanced Parkinson's disease
20 May 2022 - Submission is supported by Phase 3 study that demonstrated patients had significant increases in hours of ...
Posted by Michael Wonder on 16 May 2022
FDA rejects anti-depressant seen as possible COVID-19 treatment
16 May 2022 - The FDA declined Monday to authorise a 30 year old generic anti-depressant as a treatment for ...
Posted by Michael Wonder on 16 May 2022
Travere Therapeutics announces FDA acceptance and priority review of new drug application for sparsentan for the treatment of IgA nephropathy
16 May 2022 - PDUFA target action date of 17 November 2022. ...
Posted by Michael Wonder on 16 May 2022
scPharmaceuticals announces FDA acceptance of Furoscix new drug application
16 May 2022 - PDUFA action date set for October 8, 2022. ...
Posted by Michael Wonder on 13 May 2022
Update on U.S. FDA review of biologics license application for bimekizumab
13 May 2022 - UCB announced today that the U.S. FDA has issued a complete response letter regarding the biologics ...
Posted by Michael Wonder on 12 May 2022
FDA approves oral formulation of treatment for amyotrophic lateral sclerosis
12 May 2022 - Today, FDA approved Radicava ORS (edaravone) oral suspension for the treatment of adults with amyotrophic lateral sclerosis. ...
Posted by Michael Wonder on 12 May 2022
Moderna completes FDA submission for use of COVID shot in adolescents, kids
11 May 2022 - Moderna has made all necessary submissions required by the U.S. FDA for emergency use authorisation of ...
Posted by Michael Wonder on 11 May 2022
Amicus Therapeutics receives notification of PDUFA date extensions for AT-GAA
10 May 2022 - Amicus Therapeutics today announced that the U.S. FDA has extended the review period by 90 days ...
Posted by Michael Wonder on 10 May 2022
Eisai completes rolling submission to the U.S. FDA for biologics license application of lecanemab for early Alzheimer's disease under the accelerated approval pathway
10 May 2022 - Eisai and Biogen announced today that Eisai has completed the rolling submission to the U.S. FDA of ...
Posted by Michael Wonder on 04 May 2022
Imfinzi plus chemotherapy granted priority review in the US for patients with locally advanced or metastatic biliary tract cancer based on TOPAZ-1 Phase III trial
4 May 2022 - First Phase 3 trial in this setting to show improved overall survival with an immunotherapy added ...
Posted by Michael Wonder on 03 May 2022
U.S. FDA accepts supplemental new drug application and grants priority review for darolutamide in combination with docetaxel for metastatic hormone-sensitive prostate cancer
3 May 2022 - Application is being reviewed concurrently among participating international health authorities under the FDA Oncology Center of ...
Posted by Michael Wonder on 03 May 2022
Unwanted advice? Frequency, characteristics and outcomes of negative advisory committee votes for FDA approved drugs
2 May 2022 - Substantial controversy arose in 2021 when the FDA approved the Alzheimer’s disease drug aducanumab (Aduhelm) under its ...
Posted by Michael Wonder on 03 May 2022
HutchMed receives complete response letter from the U.S. FDA for surufatinib for the treatment of advanced neuroendocrine tumours
2 May 2022 - HutchMed announced that the U.S. FDA has issued a complete response letter regarding the new drug application ...
Posted by Michael Wonder on 02 May 2022
Sage Therapeutics and Biogen initiate rolling submission of new drug application to US FDA for zuranolone for the potential treatment of major depressive disorder
2 May 2022 - The companies expect to complete submission of the new drug application for treatment of major depressive ...
Posted by Michael Wonder on 02 May 2022
Axsome Therapeutics receives FDA complete response letter for new drug application for AXS-07 for the acute treatment of migraine
2 May 2022 - No clinical efficacy or safety issues raised and no additional clinical studies required by FDA to support ...