HHS Secretary Kennedy has also highlighted his concerns with DTC prescription drug advertisements. At the time of the ...
A wave of expiries will hit high-value assets, including Keytruda, Eliquis, Ibrance, and Trulicity, amplifying revenue vulnerability for companies with concentrated blockbuster dependence.
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 ...
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 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 ...
VRBPAC is evaluating an XFG-targeted composition for 2026–2027 vaccines, based on CDC variant prevalence estimates that are more than a month old. FDA briefing materials emphasize eroding sequencing ...
Eli Lilly enters three separate acquisitions totaling $3.83 billion in a push into vaccines and infectious diseases, signaling a strategic expansion into prevention-focused medicines. Eli Lilly ...
As FDA complete response letters continue to impact nearly half of cell and gene therapy submissions, manufacturing strategy and process design are emerging as the industry’s most persistent ...
Zepbound’s return as a preferred option reverses a prior formulary exclusion that maintained Wegovy coverage, underscoring how net pricing and rebate contracting drive PBM obesity access decisions.
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