A stepped tariff schedule targets generics only, preserving existing treatment for patented and innovative drugs while signaling punitive intent for firms that do not invest in U.S. plant and ...

Litigation targets comparative efficacy messaging that allegedly pits Zepbound 10/15 mg against Wegovy 1.7/2.4 mg while omitting FDA-approved 7.2 mg Wegovy, complicating head-to-head implications.

EUA marks the first U.S. multiplex PCR capable of differential detection of HSV-1, HSV-2, VZV, and MPXV from a single specimen. Overlapping lesion morphology makes sequential single-pathogen testing ...

Viral surveillance and predictive modeling are used to map mutational escape pathways and inform proactive antibody design against likely future variants rather than only current circulating strains.

Throughout his diverse career, he has hand-crafted bicycles, commercialized software for clinical trials, launched groundbreaking CME technologies for doctors, and introduced leading fashion ...

David Hung, president, CEO, and founder of Nuvation Bio, discusses his leadership style, emphasizing the importance of hiring ...

Gerren McHam, vice president of Government and External Affairs, API Innovation Center, describes how China’s recent export ...

FDA IND clearance enables U.S. site activation for the ongoing Phase I C-1101-101 trial, with initial dosing already completed in Australia and near-term plans to begin treating U.S. patients. C-1101 ...

In today's Pharmaceutical Executive Daily, FDA converts Fabhalta's accelerated approval to full approval for IgA nephropathy, ...

Kp-104 (vensobafusp alfa) advances as a Phase II/III-ready bifunctional complement biologic targeting alternative and terminal pathways, with rare renal Phase II basket interim reads in Q4 2026 and Q2 ...

Traditional approval was anchored on eGFR preservation rather than proteinuria surrogate, strengthening linkage to dialysis/transplantation risk reduction. APPLAUSE-IgAN showed a 2.7 mL/min/1.73 ...