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RSS FeedPosted by Michael Wonder on 23 Feb 2024
US FDA grants priority review to Harmony Biosciences' application for Wakix (pitolisant) in paediatric narcolepsy
21 February 2024 - Prescription Drug User Fee Act date is 21 June 2024. ...
Posted by Michael Wonder on 22 Feb 2024
Avidity Biosciences receives FDA rare paediatric disease designation for AOC 1044 for treatment of Duchenne muscular dystrophy in people with mutations amenable to exon 44 skipping
20 February 2024 - Avidity Biosciences today announced that the US FDA has granted rare paediatric disease designation to AOC 1044, ...
Posted by Michael Wonder on 21 Feb 2024
Linvoseltamab BLA for treatment of relapsed/refractory multiple myeloma accepted for FDA priority review
21 February 2024 - Regeneron Pharmaceuticals today announced that the US FDA has accepted for priority review the biologics license application ...
Posted by Michael Wonder on 20 Feb 2024
argenx announces FDA acceptance of supplemental biologics license application with priority review for Vyvgart Hytrulo in chronic inflammatory demyelinating polyneuropathy
20 February 2024 - Prescription Drug User Fee Act target action date is 21 June 2024. ...
Posted by Michael Wonder on 20 Feb 2024
FDA grants priority review to Merck’s application for Keytruda (pembrolizumab) plus chemotherapy as treatment for primary advanced or recurrent endometrial carcinoma
20 February 2024 - Acceptance based on results from the pivotal Phase 3 NRG-GY018 trial. ...
Posted by Michael Wonder on 20 Feb 2024
US FDA accepts supplemental new drug application for Krazati (adagrasib) in combination with cetuximab as a targeted treatment option for patients with previously treated KRAS G12C mutated locally advanced or metastatic colorectal cancer for priority review
20 February 2024 - BMS today announced that the US FDA has accepted for priority review the supplemental new drug ...
Posted by Michael Wonder on 10 Feb 2024
Lykos Therapeutics announces FDA acceptance and priority review of new drug application for MDMA assisted therapy for PTSD
9 February 2024 - PDUFA date is 11 August 2024. ...
Posted by Michael Wonder on 07 Feb 2024
GSK’s RSV vaccine, Arexvy, accepted under priority review in US for the prevention of RSV disease in adults aged 50-59 at increased risk
6 February 2024 - Application supported by positive results of a Phase 3 trial showing immune response and acceptable tolerability profile ...
Posted by Michael Wonder on 06 Feb 2024
Valneva announces sale of priority review voucher for $103 million
5 February 2024 - Valneva today announced it sold the priority review voucher it received from the US FDA for ...
Posted by Michael Wonder on 06 Feb 2024
Ultragenyx receives PRIME designation from EMA for GTX-102 for the treatment of Angelman syndrome
5 February 2024 - GTX-102 is the first Angelman syndrome therapeutic candidate to receive PRIME designation. ...
Posted by Michael Wonder on 02 Feb 2024
Tyra Biosciences receives FDA rare paediatric disease designation for TYRA-300 for the treatment of achondroplasia
1 February 2024 - Tyra Biosciences today announced that the US FDA has granted rare paediatric disease designation to TYRA-300, an ...
Posted by Michael Wonder on 01 Feb 2024
Adaptimmune announces US FDA acceptance of biologics license application for afami-cel for the treatment of advanced synovial sarcoma with priority review
31 January 2024 - Adaptimmune Therapeutics today announced that the US FDA has accepted for priority review its biologics license application ...
Posted by Michael Wonder on 29 Jan 2024
Enhertu granted priority review in the US for patients with metastatic HER2 positive solid tumours
29 January 2024 - Application based on results from DESTINY-PanTumor02 trial and supported by additional Enhertu data. ...
Posted by Michael Wonder on 23 Jan 2024
4DMT receives rare paediatric disease designation from FDA for aerosolised 4D-710 for treatment of cystic fibrosis lung disease
23 January 2024 - Interim data update from Phase 1/2 AEROW clinical trial expected in mid-2024, and pivotal trial planning ...
Posted by Michael Wonder on 19 Jan 2024
US FDA grants mesoblast rare paediatric disease designation for Revascor (Rexlemestrocel-L) in children with congenital heart disease
19 January 2024 - Revascor increases size of left heart chamber and improves surgical outcomes in children with hypoplastic left ...