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RSS FeedPosted by Michael Wonder on 22 Nov 2022
argenx announces US FDA acceptance of biologics license application for subcutaneous efgartigimod in generalised myasthenia gravis with priority review
22 November 2022 - PDUFA target action date is 20 March 2023. ...
Posted by Michael Wonder on 21 Nov 2022
US FDA accepts for priority review the biologics license application for epcoritamab (DuoBody-CD3xCD20) for the treatment of relapsed/refractory large B-cell lymphoma
21 November 2022 - The application is supported by data from EPCORE NHL-1 Phase 1/2 trial evaluating the safety and preliminary ...
Posted by Michael Wonder on 11 Nov 2022
Akari Therapeutics granted FDA rare paediatric disease designation of nomacopan for the treatment of paediatric HSCT-TMA
10 November 2022 - Akari Therapeutics today announced the US FDA has granted the rare paediatric disease designation to nomacopan for ...
Posted by Michael Wonder on 09 Nov 2022
Study: high concordance in breakthrough therapy, PRIME decisions
8 November 2022 - The US FDA and the EMA agreed on nearly two-thirds of decisions to grant or deny ...
Posted by Michael Wonder on 07 Nov 2022
Sensorion announces US FDA grants rare paediatric disease designation to OTOF-GT for the treatment of otoferlin gene-mediated hearing loss
7 November 2022 - OTOF-GT targets the restoration of hearing in people living with otoferlin deficiency. ...
Posted by Michael Wonder on 02 Nov 2022
GSK’s respiratory syncytial virus older adult vaccine candidate granted priority review by US FDA
2 November 2022 - US FDA has set a Prescription Drug User Fee Act action date of 3 May 2023. ...
Posted by Michael Wonder on 31 Oct 2022
FDA accepts for priority review Ascendis Pharma’s NDA for TransCon PTH in adult patients with hypoparathyroidism
31 October 2022 - PDUFA target action date is 30 April 2023. ...
Posted by Michael Wonder on 27 Oct 2022
AvroBio receives rare paediatric disease designation from the US FDA for first in class gene therapy for Gaucher disease
27 October 2022 - AVR-RD-02 has previously received fast track status from FDA, orphan drug designation in the US and EU, ...
Posted by Michael Wonder on 26 Oct 2022
Seres Therapeutics announces FDA acceptance of biologics license application for investigational microbiome therapeutic SER-109 for recurrent C. difficile infection for priority review
26 October 2022 - PDUFA target action date is 26 April 2023, with anticipated launch soon thereafter. ...
Posted by Michael Wonder on 24 Oct 2022
Quizartinib granted priority review in the US for patients with newly diagnosed FLT3-ITD positive acute myeloid leukaemia
24 October 2022 - Submission based on QuANTUM-First results showing quizartinib plus chemotherapy significantly improved overall survival compared to chemotherapy ...
Posted by Michael Wonder on 12 Oct 2022
Eylea (aflibercept) injection sBLA for treatment of retinopathy of prematurity accepted for FDA priority review
12 October 2022 - Regeneron Pharmaceuticals today announced the US FDA has accepted for priority review the supplemental biologics license application ...
Posted by Michael Wonder on 11 Oct 2022
Eligo Bioscience receives FDA orphan drug designation and rare paediatric disease designation for EB003 for the prevention of haemolytic uraemic syndrome with first in class CRISPR based medicine
11 October 2022 - Eligo Bioscience today announced the US FDA has granted orphan drug designation and rare paediatric disease designation ...
Posted by Michael Wonder on 11 Oct 2022
U.S. FDA accepts for priority review the supplemental biologics license application for Gilead’s Trodelvy for pre-treated HR+/HER2- metastatic breast cancer
11 October 2022 - Supplemental biologics license application based on statistically significant and clinically meaningful overall survival and progression-free survival results ...
Posted by Michael Wonder on 28 Sep 2022
CRISPR Therapeutics announces FDA regenerative medicine advanced therapy designation granted to CTX130 for the treatment of cutaneous T-cell lymphomas
28 September 2022 - CRISPR Therapeutics today announced that the US FDA granted regenerative medicine advanced therapy designation to CTX130, ...
Posted by Michael Wonder on 28 Sep 2022
Pharming announces US FDA acceptance for priority review of its new drug application for leniolisib
28 September 2022 - The FDA has assigned a PDUFA goal date of 29 March 2023 for the NDA submission based ...