Blog
RSS FeedPosted by Michael Wonder on 05 Dec 2024
Applied Therapeutics receives complete response letter from US FDA regarding new drug application for govorestat for classic galactosaemia
27 November 2024 - Applied Therapeutics today announced that the US FDA has issued a complete response letter for the ...
Posted by Michael Wonder on 05 Dec 2024
Exelixis provides regulatory update related to supplemental new drug application for cabozantinib (Cabometyx) for the treatment of patients with previously treated advanced neuroendocrine tumors
26 November 2024 - 26, 2024-- Exelixis today announced that the US FDA has notified the company that the supplemental new ...
Posted by Michael Wonder on 04 Dec 2024
Theratechnologies submits updated tesamorelin F8 formulation sBLA for FDA review
26 November 2024 - Resubmission addresses questions raised in January 2024 complete response letter. ...
Posted by Michael Wonder on 04 Dec 2024
Valneva submits label extension application for its Chikungunya vaccine, Ixchiq, to the US FDA
26 November 2024 - To potentially include adolescents and antibody persistence up to two years. ...
Posted by Michael Wonder on 04 Dec 2024
Soleno Therapeutics announces FDA extension of review period for DCCR (diazoxide choline) extended release tablets in Prader-Willi syndrome
26 November 2024 - PDUFA target action date extended by three months to 27 March 2025. ...
Posted by Michael Wonder on 04 Dec 2024
Alnylam announces US FDA acceptance of supplemental new drug application for vutrisiran for the treatment of ATTR amyloidosis with cardiomyopathy
25 November 2024 - PDUFA date set for 23 March 2025. ...
Posted by Michael Wonder on 02 Dec 2024
Blenrep combinations accepted for review by the US FDA for the treatment of relapsed/refractory multiple myeloma
25 November 2024 - Regulatory submission supported by Phase 3 head to head DREAMM-7 and DREAMM-8 trials showing statistically significant efficacy, ...
Posted by Michael Wonder on 01 Dec 2024
Amneal resubmits DHE auto-injector new drug application and receives US FDA approval of exenatide, its first generic injectable GLP-1 agonist
21 November 2024 - Potential first and only DHE auto-injector for tough-to-treat migraines and cluster headaches. ...
Posted by Michael Wonder on 30 Nov 2024
Johnson & Johnson seeks US FDA approval for subcutaneous induction regimen of Tremfya (guselkumab) in ulcerative colitis, a first for an IL-23 inhibitor
22 November 2024 - Submission is supported by the Phase 3 ASTRO study, which achieved the primary endpoint of clinical remission ...
Posted by Michael Wonder on 30 Nov 2024
US FDA accepts supplemental new drug application for Nubeqa (darolutamide) for the treatment of patients with metastatic hormone sensitive prostate cancer
21 November 2024 - Submission based on positive results from the Phase 3 ARANOTE trial which showed Nubeqa (darolutamide) plus androgen ...
Posted by Michael Wonder on 29 Nov 2024
Replimune receives breakthrough therapy designation for RP1 and submits RP1 biologics license application to the FDA under the accelerated approval pathway
21 November 2024 - Replimune today announced that it has submitted a biologics license application to the FDA for RP1 (vusolimogene ...
Posted by Michael Wonder on 27 Nov 2024
Astellas provides update on Izervay (avacincaptad pegol intravitreal solution) supplemental new drug application
19 November 2024 - Astellas today announced the US FDA issued a complete response letter on 15 November 2024, regarding the ...
Posted by Michael Wonder on 21 Nov 2024
Arrowhead Pharmaceuticals submits new drug application to US FDA for plozasiran for the treatment of familial chylomicronemia syndrome
18 November 2024 - The new drug application is based on positive results from the Phase 3 PALISADE study. ...
Posted by Michael Wonder on 15 Nov 2024
Dupixent (dupilumab) sBLA accepted for FDA review for the treatment of chronic spontaneous urticaria
15 November 2024 - Resubmission includes new pivotal data which confirm Dupixent significantly reduced itch and hive activity. ...
Posted by Michael Wonder on 12 Nov 2024
Abeona Therapeutics announces FDA acceptance of BLA resubmission of prademagene zamikeracel for the treatment of recessive dystrophic epidermolysis bullosa
12 November 2024 - Abeona Therapeutics today announced that the US FDA has accepted for review Abeona’s resubmission of its ...