Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 16 Aug 2022
Lynparza in combination with abiraterone granted priority review in the US for patients with metastatic castration-resistant prostate cancer
16 August 2022 - First PARP inhibitor to demonstrate clinical benefit in combination with a new hormonal agent irrespective of ...
Posted by Michael Wonder on 11 Aug 2022
Menarini Group’s elacestrant granted priority review by the US FDA for patients with ER+/HER2- advanced or metastatic breast cancer
11 August 2022 - US FDA has assigned a Prescription Drug User Fee Act date of 17 February 2023. ...
Posted by Michael Wonder on 01 Aug 2022
Pharming receives accelerated assessment in Europe for leniolisib for the treatment of rare immunodeficiency, APDS
1 August 2022 - Pharming is on track to submit its marketing authorisation application for leniolisib in H2 2022. ...
Posted by Michael Wonder on 01 Aug 2022
Gamida Cell announces FDA acceptance of biologics license application for omidubicel with priority review
1 August 2022 - PDUFA target action date is 30 January 2023. ...
Posted by Michael Wonder on 25 Jul 2022
Enhertu granted priority review in the U.S. for patients with HER2 low metastatic breast cancer
25 July 2022 - Application being evaluated under FDA Real-Time Oncology Review and Project Orbis. ...
Posted by Michael Wonder on 19 Jul 2022
Apellis announces FDA acceptance and priority review of the new drug application for pegcetacoplan for the treatment of geographic atrophy
19 July 2022 - PDUFA target action date is 26 November 2022. ...
Posted by Michael Wonder on 14 Jul 2022
Marinus Pharmaceuticals sells rare paediatric disease priority review voucher for $110 million
14 July 2022 - Marinus Pharmaceuticals today announced that it has entered into a definitive agreement to sell its rare ...
Posted by Michael Wonder on 07 Jul 2022
US FDA awards rare paediatric disease designation to paxalisib for AT/RT, a rare form of childhood brain cancer
6 July 2022 - Kazia Therapeutics is pleased to announce that the U.S. FDA has awarded rare paediatric disease designation ...
Posted by Michael Wonder on 06 Jul 2022
FDA grants priority review to Genentech’s mosunetuzumab for people with relapsed or refractory follicular lymphoma
6 July 2022 - Application is based on results from the pivotal Phase I/II study showing mosunetuzumab induced high and durable ...
Posted by Michael Wonder on 06 Jul 2022
The U.S. FDA accepts and grants priority review for Eisai's biologics license application of lecanemab for early Alzheimer's disease under the accelerated approval pathway
6 July 2022 - Eisai and Biogen announced today that the U.S. FDA has accepted the biologics license application under the ...
Posted by Michael Wonder on 29 Jun 2022
Bavarian Nordic announces grant of PRIME eligibility from the EMA for its RSV vaccine candidate for the prevention of respiratory syncytial virus in older adults
28 June 2022 - Bavarian Nordic announced today that the EMA has granted access to its priority medicines (PRIME) scheme for ...
Posted by Michael Wonder on 29 Jun 2022
Ipsen announces U.S. FDA priority review for palovarotene new drug application in patients with fibrodysplasia ossificans progressiva following resubmission
29 June 2022 - Ipsen today announced that the U.S. FDA has accepted for priority review its resubmitted new drug ...
Posted by Michael Wonder on 28 Jun 2022
Adverum Biotechnologies granted Priority Medicines (PRIME) designation by EMA for ADVM-022 in wet AMD
24 June 2022 - Adverum Biotechnologies today announced that the EMA has granted ADVM-022 Priority Medicines (PRIME) designation for the treatment ...
Posted by Michael Wonder on 26 Jun 2022
Emergent BioSolutions announces FDA acceptance of biologics license application for AV7909 anthrax vaccine candidate
24 June 2022 - Emergent BioSolutions announced today that the U.S. FDA accepted for review the biologics license application for AV7909 ...