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 ...
Gerren McHam, vice president of Government and External Affairs, API Innovation Center, describes how China’s recent export ...
Indication includes adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia, for LDL-C ...
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 ...
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 ...
David Hung, president, CEO, and founder of Nuvation Bio, discusses his leadership style, emphasizing the importance of hiring ...
In today's Pharmaceutical Executive Daily, FDA converts Fabhalta's accelerated approval to full approval for IgA nephropathy, ...
Approval is backed by VIKTORIA-1 (PIK3CA wild-type), a global open-label randomized trial of gedatolisib plus fulvestrant ± palbociclib after progression on CDK4/6 therapy and an aromatase inhibitor.
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.
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