Makary resigns, with Diamantas named as acting FDA commissioner
Following news that started brewing last week, Dr Marty Makary has officially resigned from his post as commissioner of the …
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Implementing AI in workflows: One step at a time
Artificial Intelligence (AI) is increasingly framed as a transformative tool that can address inefficiencies across therapeutic research and development (R&D). …
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Despite turbulence at FDA, technical staff remain “dedicated,” says CMO
It has been a turbulent few months for the US Food and Drug Administration (FDA), with redundancies, leadership changes and …
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Hantavirus outbreak demonstrates need for more antiviral agents
A hantavirus outbreak has occurred on the MV Hondius cruise ship, which left from Argentina on 1 April. It originally …
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BridgeBio’s Attruby challenges Pfizer’s Vyndamax legacy in pivotal ATTR trial
BridgeBio has revealed new pivotal trial data for Attruby (acoramidis) along with results from an indirect comparison to Pfizer’s Vyndamax …
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Despite turbulence at FDA, technical staff remain “dedicated,” says CMO
It has been a turbulent few months for the US Food and Drug Administration (FDA), with redundancies, leadership changes and …
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Hantavirus outbreak demonstrates need for more antiviral agents
A hantavirus outbreak has occurred on the MV Hondius cruise ship, which left from Argentina on 1 April. It originally …
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BridgeBio’s Attruby challenges Pfizer’s Vyndamax legacy in pivotal ATTR trial
BridgeBio has revealed new pivotal trial data for Attruby (acoramidis) along with results from an indirect comparison to Pfizer’s Vyndamax …
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MSD and Erasca collaborate on clinical trial for RAS-mutant tumours
Merck & Co (MSD) and Erasca have entered a clinical trial collaboration and supply agreement to assess ERAS-0015 in combination …
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Why single biomarkers are no longer enough: a new paradigm in colorectal cancer
In colorectal cancer (CRC), biomarkers have long been used to decide if patients are eligible for a particular therapy or …
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Inhibrx announces positive interim results from HexAgon trial
Inhibrx Biosciences has reported positive interim data from the Phase II segment of its HexAgon study assessing INBRX-106 in treatment-naïve, …
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Fractyl Health’s GLP-1 gene therapy trial given green light
Fractyl Health’s trial to evaluate a glucagon-like peptide-1 (GLP-1) gene therapy has been approved by European authorities. The open-label, first-in-human, Phase …
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WhiteSwell’s heart failure device promising but patient death rattles results
WhiteSwell has debuted promising early data from a feasibility study on its eLym system in acute decompensated heart failure (ADHF), …
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Hantavirus cruise ship outbreak: case numbers rise to ten
On 2 May 2026, the World Health Organization (WHO) was notified of an outbreak of severe acute respiratory illnesses occurring …
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FDA locks down post-approval pregnancy safety data framework
The US Food and Drug Administration (FDA) has debuted its final industry guidance on collecting post-marketing safety data for both …
