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RSS FeedPosted 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 ...
Posted by Michael Wonder on 24 Sep 2022
FDA grants rare paediatric disease designation to dovitinib for osteosarcoma
22 September 2022 - Rare paediatric disease designation qualifies Oncoheroes to receive fast track review, and a priority review voucher at ...
Posted by Michael Wonder on 20 Sep 2022
Cidara Therapeutics announces FDA acceptance for priority review of new drug application for rezafungin for the treatment of candidemia and invasive candidiasis
20 September 2022 - Assigned PDUFA target action date of 22 March 2023. ...
Posted by Michael Wonder on 20 Sep 2022
AvroBio receives rare paediatric disease designation from US FDA for first gene therapy in development for cystinosis
20 September 2022 - AVR-RD-04 has previously received orphan drug designation from FDA and EMA. ...
Posted by Michael Wonder on 19 Sep 2022
Seagen announces Tukysa (tucatinib) in combination with trastuzumab granted priority review by FDA for previously treated HER2 positive metastatic colorectal cancer
19 September 2022 - FDA has set action date of 19 January 2023 . ...
Posted by Michael Wonder on 19 Sep 2022
FDA grants Radiopharm Theranostics DUNP19 product rare paediatric disease designation
16 September 2022 - Radiopharm Theranostics has been granted rare paediatric disease designation by the US FDA for its DUNP19 ...
Posted by Michael Wonder on 15 Sep 2022
Aro Biotherapeutics receives FDA rare paediatric drug designation for ABX1100 for the treatment of Pompe disease
15 September 2022 - Aro Biotherapeutics today announced that the US FDA granted rare paediatric drug designation for ABX1100, an investigational ...
Posted by Michael Wonder on 12 Sep 2022
Acadia Pharmaceuticals announces trofinetide new drug application for the treatment of Rett syndrome has been accepted for filing and review by US FDA
12 September 2022 - Prescription Drug User Fee Act action date set for 12 March 2023. ...
Posted by Michael Wonder on 12 Sep 2022
Chiesi Global Rare Diseases announces FDA acceptance of BLA filing for velmanase alfa for the proposed treatment of alfa mannosidosis
12 September 2022 - FDA grants priority review designation with PDUFA date in the first half of 2023. ...
Posted by Michael Wonder on 30 Aug 2022
FDA grants priority review to efanesoctocog alfa for people with haemophilia A
30 August 2022 - Priority review based on pivotal data from the XTEND-1 Phase 3 study. ...
Posted by Michael Wonder on 23 Aug 2022
iECURE receives FDA rare paediatric disease designation for GTP-506, an investigational gene editing product candidate for the treatment of ornithine transcarbamylase deficiency
23 August 2022 - GTP-506, a potential single-dose gene editing therapy designed to restore metabolic function in patients suffering with OTC ...