FDA’s draft guidance allows sponsors to leverage public and platform knowledge for CMC, nonclinical, and clinical support of ...
RNA exon editing enables replacement of multiple entire exons at kilobase scale, potentially addressing large genes and high ...
The results of the survey revealed that the growing direct-to-patient approach is having a significant impact on how ...
A wave of expiries will hit high-value assets, including Keytruda, Eliquis, Ibrance, and Trulicity, amplifying revenue ...
HHS Secretary Kennedy has also highlighted his concerns with DTC prescription drug advertisements. At the time of the ...
A trio of deals from Eli Lilly, Servier, and Avenzo highlights continued industry investment in rare diseases and oncology, ...
FDA approves Shionogi’s Xocova as First Oral Post-Exposure Covid-19 Prevention Therapy, marking a major milestone for Covid-19 prevention treatments. FDA has approved Shionogi’s Xocova (ensitrelvir) ...
FDA’s CRL focused on CMC deficiencies, with no objections to clinical safety or efficacy, enabling a resubmission pathway primarily driven by manufacturing remediation. The NDA was accepted in October ...
FDA approves Gilead’s Hepcludex as the first treatment for chronic hepatitis delta virus in the U.S., marking a major ...
Phase III Tropion‑Breast02 demonstrated a 43% reduction in progression/death risk versus chemotherapy, with median overall ...
In today’s Pharmaceutical Executive Daily, Eli Lilly announces three acquisitions totaling roughly $3 billion, the FDA ...
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