The FDA has indicated that the antibody-drug conjugate looks more promising in a subgroup of EGFR mutated lung cancer patients and AstraZeneca has refiled accordingly.
AstraZeneca and partner Daiichi Sankyo have unveiled a major change of plan for the first filing of their closely-watched lung cancer therapy datopotamab deruxtecan (Dato- DXd).
The companies filed Dato-DXd with the US Food and Drug Administration for patients with advanced or metastatic nonsquamous non-small cell...
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Seven weeks before its action date, Capricor got an FDA complete response for cell therapy deramiocel in DMD-related cardiomyopathy. It has a Phase III study nearing readout, though.
Scrip spoke with executives at artificial intelligence biotech firms and a big pharma company during the recent BIO conference about using AI in ways that add real value to drug development.
The approval for young children, consistent with the FDA’s new COVID-19 vaccine policy, restricts Spikevax to those with conditions putting them at higher risk.
Lynkuet will compete with Astellas's Veozah/Veoza
The osteogenesis imperfecta drug stumbled in a second interim analysis.
The Swiss company believes its platform can make radiopharmaceuticals easier to produce and more accessible to patients.
Lupin's choice of a Cimzia biosimilar candidate and partnering with Zentiva reflect a strategy to sort the wheat from the chaff. Of 118 biologics to lose patent protection between 2025 and 2034 as per IQVIA, it’s going for a biosimilar with a single competitor though there could be other spoilers
