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RSS FeedPosted 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 ...
Posted by Michael Wonder on 18 Jan 2024
UtilityTherapeutics announces FDA acceptance of PIVYA new drug application with priority review
17 January 2024 - Utility has received a Prescription Drug User Fee Act target action date of 24 April 2024. ...
Posted by Michael Wonder on 17 Jan 2024
Atsena Therapeutics receives rare paediatric disease designation from FDA for ATSN-101 gene therapy for GUCY2D associated Leber congenital amaurosis
16 January 2023 - Atsena Therapeutics today announced the US FDA has granted rare paediatric disease designation to ATSN-101, the company’s ...
Posted by Michael Wonder on 16 Jan 2024
NRx Pharmaceuticals announces FDA qualified infectious disease product and fast track designation of NRX-101 in complicated urinary tract infection and pyelonephritis
16 January 2024 - QIDP designation grants priority review and an additional 5 years of additional product exclusivity. ...
Posted by Michael Wonder on 14 Jan 2024
Drug Farm receives rare paediatric disease designation from the US FDA for DF-003 to treat ROSAH syndrome
13 January 2024 - Drug Farm announced that the US FDA has granted rare paediatric disease designation for the company’s ...