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RSS FeedPosted by Michael Wonder on 28 Jan 2025
Beacon Therapeutics granted FDA regenerative medicine advanced therapy designation for laru-zova (AGTC-501)
28 January 2025 - Recognises preliminary clinical evidence from the Phase 2 DAWN and SKYLINE trials of laru-zova in X-linked retinitis ...
Posted by Michael Wonder on 27 Jan 2025
FDA grants priority review to Merck’s application for Welireg (belzutifan) for the treatment of patients with advanced pheochromocytoma and paraganglioma
27 January 2025 - Acceptance based on objective response rate data from the Phase 2 LITESPARK-015 trial evaluating WELIREG in certain ...
Posted by Michael Wonder on 22 Jan 2025
Replimune announces biologics license application acceptance and priority review for RP1 for the treatment of advanced melanoma
21 January 2025 - PDUFA action date of 22 July 2025, with priority review. ...
Posted by Michael Wonder on 13 Jan 2025
Datopotamab deruxtecan granted priority review in the US for patients with previously treated advanced EGFR mutated non-small cell lung cancer
13 January 2025 - Application based on TROPION-Lung05 Phase 2 trial and supported by data from TROPION-Lung01 Phase 3 and ...
Posted by Michael Wonder on 10 Jan 2025
ViGeneron announces FDA rare paediatric disease designation for VG901
8 January 2025 - ViGeneron today announced two important milestones for its novel gene therapy candidate VG901, to treat patients ...
Posted by Michael Wonder on 08 Jan 2025
US FDA granted priority review to Dizal's sunvozertinib new drug application
7 January 2025 - Sunvozertinib's new drug application was submitted based on the multinational pivotal WU-KONG1 Part B study, the ...
Posted by Michael Wonder on 31 Dec 2024
Verastem Oncology announces FDA acceptance and priority review of new drug application for avutometinib in combination with defactinib for the treatment of recurrent KRAS mutant low grade serous ovarian cancer
30 December 2024 - PDUFA target action date is 30 June 2025. ...
Posted by Michael Wonder on 19 Dec 2024
MAIA Biotechnology granted FDA rare paediatric disease designation for THIO as a treatment for paediatric high grade gliomas
16 December 2024 - MAIA Biotechnology today announced that the FDA has designated THIO for the treatment of pediatric-type diffuse high ...
Posted by Michael Wonder on 18 Dec 2024
GSK’s B7-H3 targeted antibody drug conjugate, GSK’227, receives EMA Priority Medicines (PRIME) designation in relapsed extensive-stage small-cell lung cancer
16 December 2024 - Regulatory designation based on promising preliminary clinical data. ...
Posted by Michael Wonder on 13 Dec 2024
Vir Biotechnology receives FDA breakthrough therapy designation and EMA PRIME designation for tobevibart and elebsiran in chronic hepatitis delta
12 December 2024 - Phase 3 ECLIPSE registrational program in chronic hepatitis delta to begin in the first half of 2025. ...
Posted by Michael Wonder on 12 Dec 2024
FDA grants Revescor (rexlemestrocel-L) regenerative medicine advanced therapy designation in children with congenital heart disease
5 December 2024 - Earlier this year FDA granted Revascor both rare paediatric disease designation and orphan drug designation for ...
Posted by Michael Wonder on 10 Dec 2024
MeiraGTx granted FDA regenerative medicine advanced therapy designation for AAV2-hAQP1 for the treatment of grade 2/3 radiation-induced xerostomia
9 December 2024 - MeiraGTx today announced that the US FDA has granted regenerative medicine advanced therapy designation to AAV2-hAQP1 for ...
Posted by Michael Wonder on 07 Dec 2024
Imfinzi granted priority review in the US for patients with muscle-invasive bladder cancer
6 December 2024 - Decision based on NIAGARA Phase 3 trial results which demonstrated a statistically significant and clinically meaningful ...
Posted by Michael Wonder on 07 Dec 2024
PIF Partners granted FDA rare paediatric disease designation for its proprietary small molecule in treating systemic juvenile idiopathic arthritis flares
3 December 2024 - PIF Partners announced today that the US FDA has granted rare paediatric disease designation to its proprietary ...
Posted by Michael Wonder on 03 Dec 2024
Intellia Therapeutics announces FDA regenerative medicine advanced therapy designation granted to nexiguran ziclumeran for the treatment of hereditary transthyretin amyloidosis with polyneuropathy
25 November 2024 - Intellia Therapeutics today announced that the US FDA has granted regenerative medicine advanced therapy designation to nexiguran ...