Blog
RSS FeedPosted by Michael Wonder on 09 Apr 2025
Xspray Pharma re-submits its FDA application
8 April 2024 - Xspray Pharma has re-submitted its application for market approval for Dasynoc, the company's lead product candidate, an ...
Posted by Michael Wonder on 09 Apr 2025
Tenpoint Therapeutics submits new drug application to US FDA for Brimichol PF for the treatment of presbyopia
8 April 2025 - NDA submission includes efficacy and safety data for the first fixed-dose combination therapy from the world’s ...
Posted by Michael Wonder on 09 Apr 2025
FDA approves nivolumab with ipilimumab for unresectable or metastatic MSI-H or dMMR colorectal cancer
8 April 2025 - Today, the FDA approved nivolumab (Opdivo, Bristol Myers Squibb Company) with ipilimumab (Yervoy, Bristol Myers Squibb ...
Posted by Michael Wonder on 08 Apr 2025
Kura Oncology and Kyowa Kirin announce submission of new drug application for ziftomenib to FDA
8 April 2025 - Submission seeks approval for the treatment of adult patients with relapsed or refractory AML with a ...
Posted by Michael Wonder on 08 Apr 2025
Teva announces FDA filing acceptance for Ajovy (fremanezumab) in paediatric episodic migraine prevention
7 April 2025 - If approved for an expanded paediatric indication, Ajovy would be the first calcitonin gene-related peptide antagonist for ...
Posted by Michael Wonder on 08 Apr 2025
Allogene granted three US FDA fast track designations for ALLO-329, a next generation dual targeted CD19/CD70 allogeneic CAR T for the treatment of lupus, myositis and scleroderma
7 April 2025 - Phase 1 RESOLUTION trial initiation planned for mid-2025 with initial proof of concept by year end ...
Posted by Michael Wonder on 06 Apr 2025
Update on US FDA BLA for Novavax’s COVID-19 vaccine
2 April 2025 - Novavax can confirm that 1 April 2025, was the US FDA’s Prescription Drug User Fee Act date ...
Posted by Michael Wonder on 04 Apr 2025
Aldeyra Therapeutics receives complete response letter from the US FDA for the reproxalap new drug application for the treatment of signs and symptoms of dry eye disease
3 April 2025 - Pending positive results and discussions with the FDA, new drug application resubmission expected mid 2025. ...
Posted by Michael Wonder on 04 Apr 2025
Uplinza (inebulizumab-cdon) is now the first and only FDA approved treatment for IgG4 related disease
3 April 2025 - Uplinza shown to deliver corticosteroid-free, flare-free, complete remission for patients in the MITIGATE trial. ...
Posted by Michael Wonder on 03 Apr 2025
Platform clinical trials for the efficient evaluation of multiple treatments
31 March 2025 - For some medical conditions, including conditions without effective treatments, multiple promising but unproven therapies may exist, with ...
Posted by Michael Wonder on 03 Apr 2025
Novartis receives FDA accelerated approval for Vanrafia (atrasentan), the first and only selective endothelin A receptor antagonist for proteinuria reduction in primary IgA nephropathy
3 April 2025 - Phase 3 data showed Vanrafia achieved proteinuria reduction of 36.1% (P<0.0001) vs. placebo with improvements seen at ...
Posted by Michael Wonder on 02 Apr 2025
Denali Therapeutics announces initiation of BLA filing for accelerated approval of tividenofusp alfa for the treatment of Hunter syndrome
2 April 2025 - Rolling submission of BLA initiated for tividenofusp alfa; preparations ongoing for potential US commercial launch in late ...
Posted by Michael Wonder on 02 Apr 2025
Biogen’s investigational tau-targeting therapy BIIB080 receives FDA fast track designation for the treatment of Alzheimer’s disease
2 April 2025 - Biogen today announced that the US FDA has granted fast track designation to BIIB080, an investigational ...
Posted by Michael Wonder on 02 Apr 2025
Apellis announces FDA acceptance and priority review of the supplemental new drug application for Empaveli (pegcetacoplan) for C3G and primary IC-MPGN
1 April 2025 - PDUFA target action date is 28 July 2025. ...
Posted by Michael Wonder on 01 Apr 2025
Vanda Pharmaceuticals announces the submission of an NDA to the FDA for Bysanti for the treatments of acute bipolar I disorder and schizophrenia
31 March 2025 - Vanda Pharmaceuticals today announced that a new drug application was submitted to the US FDA requesting marketing ...