Akeso eyes mAb approval after double Phase III win
Akeso’s monoclonal antibodies (mAbs) gumokimab and manfidokimab have met their primary endpoints during Phase III trials in ankylosing spondylitis (AS) …
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WCG unveils clinical trial training solution to cut deviations
WCG has introduced Total Training, a clinical trial solution designed to reduce protocol deviations and enhance site readiness, engagement, and …
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FDA approves Coya Therapeutics’ trial of COYA 302 for ALS
Coya Therapeutics has announced the acceptance by the US Food and Drug Administration (FDA) of its investigational new drug (IND) application …
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BlossomHill doses first patient in SOLARA study’s expansion cohorts
BlossomHill Therapeutics has dosed the first subject in the expansion cohorts of the SOLARA Phase I/II trial to evaluate BH-30643 …
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Lighthouse secures $49.2m NIA grant for Alzheimer’s therapy trial
Lighthouse Pharmaceuticals has secured a grant of $49.2m from the National Institute on Aging (NIA), a division of the National …
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Animal testing alternatives to dominate, but not overnight
In a bid to prioritise more human-relevant models, the US Food and Drug Administration (FDA) has enforced a plan to …
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AbbVie seeks Rinvoq alopecia approval after second Phase III success
AbbVie’s star Janus kinase (JAK) inhibitor, Rinvoq (upadacitinib), has met its primary endpoints in a second Phase III study in …
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Navigating regulatory change in APAC: Insights from the upcoming BioSecure Act Webinar
The regulatory landscape across the Asia-Pacific (APAC) region is evolving rapidly, and pharmaceutical companies must adapt to maintain compliance, mitigate …
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Dynavax’s shingles vaccine shows promise in trial against GSK’s Shingrix
Dynavax Technologies has revealed promising topline outcomes from the initial part of its Phase I/II clinical trial, comparing its shingles …
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Tyra Biosciences initiates paediatric study for achondroplasia treatment
US-based Tyra Biosciences has dosed the first paediatric participant in the dose-escalation/dose-expansion Phase II BEACH301 trial designed to assess the …
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Padcev-Keytruda combo approved for NHS use in mUC
The UK’s National Institute for Health and Care Excellence (NICE) has recommended a new combination regimen in metastatic urothelial carcinoma …
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Advancing rare disease trials by overcoming patient recruitment challenges
In September 2025, clinical development and clinical operations professionals will gather and discuss the current challenges in running clinical trials …
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Scipher Medicine introduces AI platform to forecast trial failure
Precision immunology company Scipher Medicine has introduced the ClinicalTrialRank.com AI platform to the public, designed to forecast the likelihood of …
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Rocket to relaunch rare disease trial after FDA approval
The US Food and Drug Administration (FDA) has given Rocket Pharmaceuticals approval to continue its pivotal Phase II trial of …
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Neurizon’s ALS expansion data supports NUZ-001 advancement to HEALEY trial
Neurizon Therapeutics’ disease-modifying drug NUZ-001 has been shown to be safe and effective over 2.5 years of dosing in patients …
