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The firm said the agency cited chemistry, manufacturing, and controls issues in its complete response letter, but had no concerns about product quality.
Based on data from the BEACON and NAUTICAL studies, regulatory authorities greenlit the combo for later-line patients.
ARPA-H, part of HHS, has earmarked up to $142 million for 10 research projects building the tools, data, and infrastructure needed to tackle treatment resistance.
The new dosing schedule with a more gradual titration significantly lowered incidence of ARIA-E in the TRAILBLAZER-ALZ 6 trial.
A team at the Peter Mac is planning for first-in-human trials in five years, hoping this new therapy will eschew the ...
NEW YORK – CAR T-cell therapy developer Cargo Therapeutics earlier this week announced it will be bought by Concentra Biosciences.
The drug, which Repare recently sidelined, has shown promising activity in a patient with ALT-positive melanoma that researchers want to study in others.
The funds will help the firm advance copper-based radioligand therapies and imaging agents in prostate, neuroendocrine, and breast cancers.