In drug development news, FDA granted accelerated approval for Boehringer’s Hernexeos (zongertinib) as a first-line HER2-mutant non-small cell lung cancer treatment in just 44 days, utilizing the ...
Norgine invests £23 million in Wales site to modernize production and boost resilience for UK and European medicine supply chains.
AI accelerates biopharma from discovery to production, cutting cycle times by up to 40%.
As sponsors advanced more niche and personalized modalities, manufacturers were pushed to adopt holistic approaches to safety ...
US early-phase trial velocity is constrained by hospital contracting, IRB workflows, and IND review timelines, elevating the ...
1. FDA. FDA Warns 30 Telehealth Companies Against Illegal Marketing of Compounded GLP-1s. FDA News Release. March 3, 2026.
FDA's Plausible Mechanism Framework streamlines individualized therapy approvals for ultra-rare diseases.
The rapid pace of digitalization has created a skills gap, necessitating that staff with traditional chemistry or biology degrees upskill in the IT sector . BioVectra addresses this by collaborating ...
Novo Nordisk invests €432M ($506M) in Athlone, Ireland to boost oral glucagon-like peptide-1 manufacturing capacity for global markets by 2028.
A: No new regulations were published in 2025 specific to data integrity. The evolving global regulatory systems do, however, ...
FDA expanded zongertinib’s accelerated approval to treatment-naïve HER2-mutant advanced NSCLC, contingent on mutation ...
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