FDA grants priority review for Addyi (flibanserin) paving the way for expanded access to treat low sexual desire in post-menopausal women

24 July 2025 -  Sprout Pharmaceuticals today announced that the US FDA has granted priority review for its supplemental application ...

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Commissioner's National Priority Voucher Pilot Program

22 July 2025 - Accelerated drug review for companies supporting US national interests. ...

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Rocket Pharmaceuticals receives FDA regenerative medicine advanced therapy designation for RP-A601 gene therapy for PKP2 arhythmogenic cardiomyopathy

17 July 2025 - -- Rocket Pharmaceuticals today announced that the US FDA has granted regenerative medicine advanced therapy designation to ...

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Genascence announces US FDA grants regenerative medicine advanced therapy designation to GNSC-001 for knee osteoarthritis

16 July 2025 - Genascence Corporation today announced that the US FDA has granted the regenerative medicine advanced therapy designation ...

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Johnson & Johnson receives US FDA priority review for TAR-200 NDA in high-risk non-muscle invasive bladder cancer

17 July 2025 - New drug application supported by results from the Phase 2b SunRISe-1 study. ...

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Taxis Pharmaceuticals earns FDA QIDP designation for TXA14007, an investigational efflux pump inhibitor to combat antibiotic resistant pneumonia

15 July 2025 - Taxis Pharmaceuticals announced today that it has received an FDA qualified infectious disease product designation for TXA14007, ...

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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. ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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