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 ...

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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 ...

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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 ...

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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. ...

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Takeda announces US FDA approval of Gammagard Liquid ERC, the only ready to use liquid immunoglobulin therapy with low immunoglobulin A content

30 June 2025 - US commercialisation of Gammagard Liquid ERC projected to begin in 2026. ...

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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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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 ...

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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. ...

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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. ...

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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 ...

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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. ...

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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 approves updated label for Lilly’s Amyvid (florbetapir F 18 injection) to support diagnosis of Alzheimer’s disease in patients

25 June 2025 -  Eli Lilly announced that the US FDA has approved a label update for Amyvid (florbetapir F ...

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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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