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RSS FeedPosted by Michael Wonder on 07 Dec 2023
Ipsen confirms US FDA grants priority review for new drug application for elafibranor for the treatment of rare cholestatic liver disease, PBC
7 December 2023 - New drug application granted priority review with PDUFA date set for 10 June 2024. ...
Posted by Michael Wonder on 06 Dec 2023
FDA grants priority review of ImmunoGen’s supplemental biologics license application for Elahere (mirvetuximab soravtansine-gynx) in platinum-resistant ovarian cancer
5 December 2023 - Priority review granted with PDUFA date of 5 April 2024. ...
Posted by Michael Wonder on 05 Dec 2023
Osteal Therapeutics’ VT-X7 receives FDA’s breakthrough therapy designation for the treatment of periprosthetic joint infection of the hip and knee
5 December 2023 - The US FDA granted breakthrough therapy designation for VT-X7, Osteal Therapeutics’ investigational drug therapy for periprosthetic joint ...
Posted by Michael Wonder on 05 Dec 2023
US FDA accepts for priority review Bristol Myers Squibb’s application for Opdivo (nivolumab) in combination with cisplatin-based chemotherapy for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma
5 December 2023 - The US FDA assigned a target action date of 5 April 2024. ...
Posted by Michael Wonder on 02 Dec 2023
FDA grants priority review to Merck’s application for Keytruda (pembrolizumab) plus Padcev (enfortumab vedotin-ejfv) for the first-line treatment of patients with locally advanced or metastatic urothelial cancer
30 November 2023 - Acceptance based on results from the Phase 3 KEYNOTE-A39 trial, which showed a statistically significant and ...
Posted by Michael Wonder on 30 Nov 2023
FDA grants priority review for supplemental biologics license application of Padcev (enfortumab vedotin-ejfv) with Keytruda (pembrolizumab) for first-line treatment of advanced bladder cancer
30 November 2023 - Results of pivotal confirmatory trial found the enfortumab vedotin plus pembrolizumab combination significantly extended overall survival and ...
Posted by Michael Wonder on 28 Nov 2023
Sernova receives orphan drug and rare paediatric disease designations for its haemophilia A program from FDA
27 November 2023 - Sernova today announced the US FDA has granted both orphan drug designation and rare paediatric disease designation ...
Posted by Michael Wonder on 14 Nov 2023
Atsena Therapeutics receives FDA regenerative medicine advanced therapy designation for ATSN-101 gene therapy for GUCY2D associated Leber congenital amaurosis
14 November 2023 - ATSN-101 has demonstrated clinically meaningful improvements in vision at the highest dose with no drug-related serious ...
Posted by Michael Wonder on 01 Nov 2023
X4 Pharmaceuticals announces FDA acceptance with priority review of US NDA for mavorixafor in WHIM syndrome
31 October 2023 - FDA sets a PDUFA target action date of 30 April 2024. ...
Posted by Michael Wonder on 31 Oct 2023
US FDA awards both rare paediatric disease and orphan drug designations to HG204, a CRISPR RNA editing therapy, for the treatment of MECP2 duplication syndrome
31 October 2023 - HG204 is the world first CRISPR RNA-editing therapy for the treatment of MECP2 duplication syndrome granted ...
Posted by Michael Wonder on 30 Oct 2023
bluebird bio enters into advance agreement to sell priority review voucher, if granted, for $103 million
30 October 2023 - bluebird bio today announced that it has entered into an agreement to sell a rare paediatric disease ...
Posted by Michael Wonder on 24 Oct 2023
Immatics receives FDA regenerative medicine advanced therapy designation for ACTengine IMA203 TCR-T monotherapy
24 October 2023 - Regulatory activities underway with an initial focus on a registration directed trial in melanoma as step ...
Posted by Michael Wonder on 17 Oct 2023
NorthSea Therapeutics receives FDA rare paediatric disease designation for SEFA-6179 for the treatment of intestinal failure-associated liver disease
17 October 2023 - Rare paediatric disease designation underscores critical need for novel therapies to address IFALD. ...
Posted by Michael Wonder on 16 Oct 2023
Editas Medicine granted FDA regenerative medicine advanced therapy designation for EDIT-301 for the treatment of severe sickle cell disease
16 October 2023 - Editas Medicine today announced that the US FDA granted regenerative medicine advanced therapy designation to EDIT-301, an ...
Posted by Michael Wonder on 16 Oct 2023
Tagrisso plus chemotherapy granted priority review in the US for patients with EGFR mutated advanced lung cancer
16 October 2023 - Decision based on FLAURA2 Phase 3 trial results which extended median progression-free survival by nearly 9 ...