The regulator approved the indication based on data showing Kisqali with an aromatase inhibitor improved invasive disease-free survival versus just an aromatase inhibitor.
The FDA has offered positive feedback on possible paths forward for accelerated or traditional approval of FLT201 using data from a single-arm study.
The committee recommended the new formulation in two EGFR-mutated advanced NSCLC settings, for which intravenous Rybrevant is already available.
The firm will begin testing a second dose cohort with AMT-191 after receiving a positive recommendation from a data monitoring committee.
These boards are cropping up around the US as neurologists acclimate to a new class of drugs, but not everyone agrees such ...
The FDA, which has stopped short of requiring DPYD testing for patients before receiving fluoropyrimidines, emphasized the ...
The positive results from the second part of the EMBARK trial contrast with findings from one-year post treatment, which did ...
In a Phase I/II trial, patients with X-linked chronic granulomatous disease will receive a treatment created using a new ...
NEW YORK – AstraZeneca and Daiichi Sankyo have begun treating high-risk non-small cell lung cancer patients with their TROP2-directed antibody drug conjugate Datroway (datopotamab deruxtecan) and ...
NEW YORK – Fractyl Health on Friday said it intends to initiate a first-in-human trial of a gene therapy it's developing to treat type 2 diabetes, RJVA-001, in the first half of 2025. Burlington, ...
NEW YORK – The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on Thursday recommended approval for Bristol Myers Squibb's autologous CAR T-cell therapy Breyanzi ...
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