Blog
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 07 Jul 2025
KalVista Pharmaceuticals announces FDA Approval of Ekterly (sebetralstat), first and only oral on-demand treatment for hereditary angioedema
7 July 2025 - First new on demand hereditary angioedema treatment in over a decade, with potential to transform management of the ...
Posted by Michael Wonder on 03 Jul 2025
FDA grants accelerated approval to sunvozertinib for metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations
2 July 2025 - Today, the FDA granted accelerated approval to sunvozertinib (Zegfrovy, Dizal) for adult patients with locally advanced ...
Posted by Michael Wonder on 03 Jul 2025
FDA grants priority review for Winrevair (sotatercept-csrk) to update label based on results from ZENITH trial
2 July 2025 - Merck today announced that the US FDA has accepted and granted priority review for a new supplemental ...
Posted by Michael Wonder on 03 Jul 2025
FDA grants accelerated approval to linvoseltamab-gcpt for relapsed or refractory multiple myeloma
2 July 2025 - Today the FDA granted accelerated approval to linvoseltamab-gcpt (Lynozyfic, Regeneron Pharmaceuticals), a bispecific B-cell maturation antigen ...
Posted by Michael Wonder on 01 Jul 2025
Unicycive Therapeutics announces receipt of complete response letter for oxylanthanum carbonate for the treatment of hyperphosphataemia in patients with chronic kidney disease on dialysis
30 June 2025 - No other concerns stated, including pre-clinical, clinical, or safety data. ...
Posted by Michael Wonder on 28 Jun 2025
FDA approves Gamifant (emapalumab-lzsg) as first-ever treatment for adults and children with Macrophage Activation Syndrome in Still's disease
28 June 2025 - Approval based on the pooled analysis of our pivotal EMERALD and NI-0501-06 studies, showing 54% of ...
Posted by Michael Wonder on 27 Jun 2025
Ultragenyx receives breakthrough therapy designation for GTX-102 in Angelman syndrome
27 June 2025 - Phase 3 Aspire study enrollment on track to complete in 2025. ...
Posted by Michael Wonder on 27 Jun 2025
Schrödinger receives fast track designation for SGR-1505 for the treatment of relapsed/refractory Waldenström's macroglobulinemia
27 June 2025 - Demonstrates the potential of SGR-1505 as a novel approach for diseases with high unmet medical need. ...
Posted by Michael Wonder on 27 Jun 2025
Achieve Life Sciences announces submission of NDA to FDA for cytisinicline as a treatment of nicotine dependence for smoking cessation
26 June 2025 - More than 2,000 clinical trial participants contributed to the body of evidence submitted in the new drug ...
Posted by Michael Wonder on 26 Jun 2025
Grace Therapeutics announces submission of new drug application to US FDA for GTx-104
25 June 2025 - Comprehensive data package includes positive results from Phase 3 STRIVE-ON safety trial of GTx-104. ...
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 25 Jun 2025
FDA approves Benlysta (belimumab) auto-injector for children with active lupus nephritis
24 June 2025 - With this approval, paediatric patients aged five years and older with active lupus nephritis will have ...