Fulcrum announced in June it would seek strategic alternatives after U.S. regulators expressed concern over the viability of ...
Submission readiness extends beyond content. Early regulatory operations planning supports a compliant, high-quality ...
An interim data check revealed that survival goals were likely to be missed by volrustomig, one in a list of new drugs the ...
Though its drug missed the key goal of a wet AMD study, EyePoint — as well as analysts — see a path toward approval.
The latest results give investors confidence in the drug's ability to be approved in another indication for which there are ...
New government funding from Pennsylvania to Kansas City is strengthening biotech hubs — but experts say money alone won’t ...
The clearance of Zenbexus is the first for a group of protein-degrading “CELMoD” medicines that could help Bristol Myers ...
The startup is one of at least a few young companies zeroing in on the rare bleeding disorder, hereditary hemorrhagic ...
The findings position their drug, zipalertinib, as a threat to multiple approved medicines — while setting a bar for others ...
The startup is the 12th drug company to bank at least $250 million in an IPO this year, nearly matching totals last seen ...
The clearance paves the way for the first preventive flu shot based on mRNA technology and completes a dramatic regulatory ...
The accelerated clearance follows two earlier rejections and the support of an advisory panel that disputed the arguments of ...
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