FDA approves updated label for Lilly's Kisunla (donanemab-azbt) with new dosing in early symptomatic Alzheimer's disease

9 July 2025 - The newly recommended dosing schedule significantly lowered ARIA-E rates compared to the original dosing schedule, adding ...

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New Wegovy dose submitted to EMA for approval, with 1 in 3 trial participants achieving 25% or more weight loss

8 July 2025 - Novo Nordisk today announced the submission of an application to the EMA for approval of a new, ...

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Supplemental new drug application submitted to US FDA for Caplyta (lumateperone) with data demonstrating significant schizophrenia relapse prevention compared to placebo

8 July 2025 - Submission is based on long-term Phase 3 data demonstrating 63 percent reduction in risk of relapse in ...

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Lexeo Therapeutics announces FDA breakthrough therapy designation for LX2006 in Friedreich ataxia

7 July 2025 - Breakthrough therapy designation based on interim clinical data from Phase I/II trials showing clinically meaningful improvements in ...

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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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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 ...

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Vitalgen's gene therapy drug VGN-R09b for primary Parkinson's disease receives FDA fast track designation

26 June 2025 - Shanghai Vitalgen announced that its gene therapy drug, VGN-R09b, for the treatment of primary Parkinson’s disease, has ...

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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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Vertex Announces European Commission approval of Alyftek, a new once daily CFTR modulator for the treatment of cystic fibrosis

1 July 2025 - Approximately 31,000 people with cystic fibrosis in the EU are now eligible for this new highly ...

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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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