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 ...

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 ...

Extensive background and on-study uptake of TTR stabilizers likely diluted the observable marginal effect of a TTR-silencing agent, complicating attribution of benefit in the intent-to-treat primary ...

In today's Pharmaceutical Executive Daily, FDA approves Ennumo, a pharma roundup covers Chemomab Therapeutics' merger with AI ...

Jay Bregman, CEO and co-founder of Andel, discusses how FDA’s action signals a broader regulatory recalibration aimed at protecting intellectual property and explores the second-order effects. Jay ...

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 ...

FDA cleared Ennumo as a Neulasta biosimilar for febrile neutropenia prophylaxis in non-myeloid malignancy patients receiving myelosuppressive chemotherapy, including pediatric populations from ...

Welcome to Pharmaceutical Executive Daily, your quick briefing on the top news shaping the pharmaceutical and life sciences ...

Zymeworks will pay $17.00/share (~$929M) for Theravance, prioritizing Yupelri-linked profitability and planned post-close ...

Bansi Nagji, CEO of PANTHERx Rare, explores how innovation is increasingly directed toward rare and orphan diseases, driven ...

Resilient field models emphasize continuous territory coverage via agile deployment, blending scalable virtual reach with ...