In today's Pharmaceutical Executive Daily, Steer Bio discusses its regenerative cell therapy platform for cancer-related lymphedema, FDA approves Celcuity's Revtorpyk as the first pan-PI3K and ...

In today's Pharmaceutical Executive Daily, AstraZeneca acquires global rights to Dizal Pharmaceutical's lung cancer drug Zegfrovy in a deal worth up to $1.5 billion, FDA approves a subcutaneous ...

A look at how to develop a generic drug and the resources FDA supplies to Abbreviated New Drug Application applications.

A two-track structure combines AI-native target discovery and generative chemistry with formulation, CMC, regulatory strategy, tech transfer, scale-up, and commercial supply to shorten the molecule-to ...

Once-weekly subcutaneous initiation dosing offers an at-home alternative for adults with MCI or mild dementia due to Alzheimer’s disease, potentially reducing infusion-center dependence and visit ...

LillyDirect exemplifies DTP as a demand-unlocking commercial channel rather than a compliance tactic, with executives ...

Pharmaceutical Executive recently spoke with Nuvation Bio’s president, CEO, and founder David Hung. The growing biotech is ...

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 ...

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 ...

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 ...