European Commission approves Biocon biologics’ denosumab biosimilars

3 July 2025 - Biocon Biologics today announced that the European Commission has granted marketing authorisation in the European Union ...

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Imfinzi approved in the EU as first and only peri-operative immunotherapy for muscle-invasive bladder cancer

4 July 2025 - Approval based on NIAGARA Phase III trial results which showed a 32% reduction in the risk ...

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Jazz Pharmaceuticals receives European Commission marketing authorisation for Ziihera (zanidatamab) for the treatment of advanced HER2 positive biliary tract cancer

1 July 2025 - Conditional approval based on positive results from the HERIZON-BTC-01 Phase 2b trial. ...

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Johnson & Johnson submits application to the EMA seeking indication extension of Akeega (niraparib and abiraterone acetate dual action tablet) for the treatment of adult patients with metastatic hormone-sensitive prostate cancer and HRR gene alterations

3 July 2025 - The submission is based on results from the Phase 3 AMPLITUDE study evaluating niraparib in combination with ...

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Apotex receives Health Canada approval for Aflivu, a biosimilar to Eylea, available in pre-filled syringe and vial formats

2 July 2025 - Apotex today announced that Health Canada has approved Aflivu (aflibercept), a biosimilar to Eylea, indicated for ...

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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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Eylea 8 mg with extended 6 month treatment interval approved in the EU

27 June 2025 - The European Commission has granted a label extension in the EU for Eylea 8 mg (aflibercept 8 ...

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Biocon Biologics receives Health Canada approval for Yesafili (aflibercept); first global launch scheduled for July 2025

27 June 2025 - Biocon Biologics is pleased to announce that Health Canada has granted a Notice of Compliance for Yesafili ...

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Omeros submits narsoplimab marketing authorization application to the EMA for the treatment of TA-TMA

27 June 2025 - Omeros Corporation today announced the recent submission of a marketing authorisation application to the EMA for ...

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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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Sephience (sepiapterin) granted marketing authorisation by the European Commission for the treatment of children and adults living with phenylketonuria

23 June 2025 - Launch to be initiated in Germany. ...

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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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