Blog
RSS FeedPosted by Michael Wonder on 05 Apr 2021
FDA approvals strengthen Octapharma USA paediatric critical care product portfolio
30 March 2021 - Octaplas and fibryga receive new product labeling following FDA’s approval of BLA supplements to update therapy ...
Posted by Michael Wonder on 02 Apr 2021
AbbVie announces extension of review for supplemental new drug application of upadacitinib for the treatment of moderate to severe atopic dermatitis
2 April 2021 - AbbVie announced that the U.S. FDA has extended the review period for the supplemental new drug application ...
Posted by Michael Wonder on 01 Apr 2021
FDA grants breakthrough therapy designation for Taiho Oncology's futibatinib for treatment of advanced cholangiocarcinoma
1 April 2021 - Taiho Oncology today announced that the U.S. FDA has granted breakthrough therapy designation for futibatinib (TAS-120), a ...
Posted by Michael Wonder on 31 Mar 2021
FDA approves Sarclisa (isatuximab) in combination with carfilzomib and dexamethasone for patients with relapsed or refractory multiple myeloma
31 March 2021 - While the median progression free survival for Sarclisa combination therapy is not yet reached, consistent improvement in ...
Posted by Michael Wonder on 31 Mar 2021
Premia Spine announces FDA breakthrough device designation for its TOPS spinal arthroplasty system
31 March 2021 - First-of-a-kind system designed to offer new treatment option for patients with spinal stenosis and spondylolisthesis. ...
Posted by Michael Wonder on 31 Mar 2021
Bluestar Genomics receives FDA breakthrough device designation for first-of-its-kind pancreatic cancer screening test
31 March 2021 - Company accelerates commercialisation efforts to address a million at-risk patients’ unmet needs. ...
Posted by Michael Wonder on 31 Mar 2021
Biden in no rush to pick new FDA chief
30 March 2021 - More than two months into his presidency, President Joe Biden has yet to name someone to lead ...
Posted by Michael Wonder on 31 Mar 2021
Jazz Pharmaceuticals announces FDA approval of additional indication for Vyxeos (daunorubicin and cytarabine) for the treatment of secondary acute myeloid leukaemia in paediatric patients
30 March 2021 - Jazz Pharmaceuticals today announced that the U.S. FDA approved a revised label for Vyxeos (daunorubicin and ...
Posted by Michael Wonder on 30 Mar 2021
Moleculin receives FDA approval of fast track designation for annamycin in the treatment of sarcoma lung metastases
30 March 2021 - Moleculin Biotech today announced that the U.S. FDA has approved its request for fast track designation for ...
Posted by Michael Wonder on 30 Mar 2021
Akebia submits new drug application to the FDA for vadadustat for the treatment of anaemia due to chronic kidney disease in adult patients on dialysis and not on dialysis
30 March 2021 - Akebia Therapeutics today announced that it has submitted a new drug application to the U.S. FDA ...
Posted by Michael Wonder on 30 Mar 2021
U.S. FDA accepts AbbVie's new drug application for atogepant for the preventive treatment of migraine
30 March 2021 - If approved, atogepant will be the first and only oral CGRP receptor antagonist specifically developed for the ...
Posted by Michael Wonder on 29 Mar 2021
TG Therapeutics completes rolling submission of biologics license application to the U.S. FDA for ublituximab in combination with Ukoniq (umbralisib) as a treatment for patients with chronic lymphocytic leukaemia
29 March 2021 - TG Therapeutics today announced the completion of the rolling submission of a biologics license application to the ...
Posted by Michael Wonder on 29 Mar 2021
Merck receives complete response letter from US FDA for supplemental biologics license application for Keytruda (pembrolizumab) in high risk early stage triple negative breast cancer
29 March 2021 - Merck today announced that the U.S. FDA has issued a complete response letter regarding Merck’s supplemental biologics ...
Posted by Michael Wonder on 29 Mar 2021
Mirum Pharmaceuticals announces FDA acceptance of new drug application and priority review for maralixibat in Alagille syndrome
29 March 2021 - PDUFA action date is 29 September 2021. ...
Posted by Michael Wonder on 29 Mar 2021
Amazon gets emergency FDA approval for at-home COVID-19 test kit
26 March 2021 - Amazon on Friday received emergency use authorisation from the FDA for an at-home COVID-19 testing kit that ...