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RSS FeedPosted by Michael Wonder on 08 Jul 2025
Denali Therapeutics announces FDA acceptance and priority review of biologics license application for tividenofusp alfa for Hunter syndrome
7 July 2025 - FDA assigns PDUFA target action date of 5 January 2026, for decision on accelerated approval. ...
Posted by Michael Wonder on 30 Jun 2025
Minovia Therapeutics announces FDA fast track and rare paediatric disease designations for MNV-201 in Pearson syndrome
30 June 2025 - Minovia Therapeutics announces that the US FDA has granted fast track designation to the Company’s lead investigational ...
Posted by Michael Wonder on 26 Jun 2025
Precision BioSciences receives FDA rare paediatric disease designation for PBGENE-DMD for the treatment of Duchenne muscular dystrophy
25 June 2025 - Precision BioSciences today announced that the US FDA has granted rare paediatric disease designation for PBGENE-DMD for ...
Posted by Michael Wonder on 26 Jun 2025
FDA grants RMAT designation for enGene’s detalimogene, enabling potential for expedited review in high risk, non-muscle invasive bladder cancer
25 June 2025 - enGene Holdings today announced that the US FDA has granted regenerative medicine advanced therapy designation to detalimogene ...
Posted by Michael Wonder on 25 Jun 2025
Novadip receives RMAT designation for NVD003, its regenerative treatment for congenital pseudarthosis of the tibia
23 June 2025 - Novadip Biosciences is developing NVD003, an autologous therapy derived from adipose stem cells, as a potential ...
Posted by Michael Wonder on 25 Jun 2025
Quoin Pharmaceuticals announces FDA grants rare paediatric disease designation for QRX003 in Netherton syndrome
24 June 2025 - Quoin Pharmaceuticals today announced that the US FDA has granted rare paediatric disease designation for the ...
Posted by Michael Wonder on 25 Jun 2025
Syndax announces FDA priority review of sNDA for Revuforj (revumenib) in relapsed or refractory mNPM1 acute myeloid leukaemia
24 June 2025 - Syndax Pharmaceuticals today announced that the US FDA has granted priority review for its supplemental new drug ...
Posted by Michael Wonder on 18 Jun 2025
FDA to issue new Commissioner’s national priority vouchers to companies supporting US national interests
17 June 2025 - The US FDA today announced its Commissioner’s National Priority Voucher program to enhance the health interests of ...
Posted by Michael Wonder on 18 Jun 2025
Bavarian Nordic announces sale of priority review voucher for USD 160 million
18 June 2025 - Bavarian Nordic announced today that it has entered into an agreement to sell its priority review ...
Posted by Michael Wonder on 13 Jun 2025
FDA grants priority review for zoliflodacin new drug application for the treatment of uncomplicated gonorrhoea
12 June 2025 - Innoviva Specialty Therapeutics today announced that the US FDA has granted priority review for the new drug ...
Posted by Michael Wonder on 12 Jun 2025
Oxford vaccine against deadly Nipah virus granted EMA PRIME designation
11 June 2025 - The University of Oxford’s vaccine to protect people from deadly Nipah virus has been granted support from ...
Posted by Michael Wonder on 02 Jun 2025
FDA accepts TransCon CNP NDA for priority review
2 June 2025 - Ascendis Pharma today announced that the US FDA has accepted for priority review its new drug application ...
Posted by Michael Wonder on 28 May 2025
Candel Therapeutics receives FDA regenerative medicine advanced therapy designation for CAN-2409 for the treatment of prostate cancer
28 May 2025 - Candel Therapeutics today announced that the US FDA has granted regenerative medicine advanced therapy designation to CAN-2409 ...
Posted by Michael Wonder on 28 May 2025
US FDA accepts new drug application under priority review for sevabertinib (BAY 2927088) in HER2 mutant non-small cell lung cancer
28 May 2025 - Regulatory submission is based on positive results from the on-going Phase I/II SOHO-01 trial in patients with ...
Posted by Michael Wonder on 28 May 2025
Ocugen announces rare paediatric disease designation granted for OCU410ST—modifier gene therapy for the treatment of Stargardt disease
27 May 2025 - Ocugen today announced that the US FDA has granted rare paediatric disease designation for OCU410ST for the ...