Pharmaceutical Executive recently spoke with Nuvation Bio’s president, CEO, and founder David Hung. The growing biotech is ...
LillyDirect exemplifies DTP as a demand-unlocking commercial channel rather than a compliance tactic, with executives ...
A cGMP-related CRL can delay approval despite substantial efficacy/safety evidence and often requires manufacturing remediation and reinspection rather than additional clinical trials. Phase III CARES ...
Modern biopharma firms are adapting their R&D investment strategies in response to challenges such as the impending $300 ...
Sanofi Chief Digital Officer Emmanuel Frenehard on scaling AI across a Big Pharma global enterprise and why a strategy of ...
It is also why I have spent over fifteen years building around a conviction the healthcare industry still resists: when ...
FDA’s July 2025 transparency initiative published 200+ redacted CRLs across drugs, biosimilars, and devices, offering granular insight into approvability deficiencies and review logic beyond ...
Welcome to Pharmaceutical Executive Daily, your quick briefing on the top news shaping the pharmaceutical and life sciences ...
Approval was supported by IRAKLIA Phase III non-inferiority data comparing on-body injector subcutaneous isatuximab to weight-based IV, both combined with pomalidomide and dexamethasone in R/R myeloma ...
In today's Pharmaceutical Executive Daily, FDA approves Ennumo, a pharma roundup covers Chemomab Therapeutics' merger with AI ...
Transaction terms include $85-per-share all-cash consideration (~$10B enterprise value) and an anticipated Q3 2026 close, contingent on customary conditions. Portfolio fit emphasizes serious, ...
The collaboration is positioned as a translational bridge for researchers and entrepreneurs, offering an end-to-end discovery ...