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%.
1. FDA. FDA Warns 30 Telehealth Companies Against Illegal Marketing of Compounded GLP-1s. FDA News Release. March 3, 2026.
As sponsors advanced more niche and personalized modalities, manufacturers were pushed to adopt holistic approaches to safety ...
AI accelerates biopharma from discovery to production, cutting cycle times by up to 40%.
FDA's Plausible Mechanism Framework streamlines individualized therapy approvals for ultra-rare diseases.
FDA expanded zongertinib’s accelerated approval to treatment-naïve HER2-mutant advanced NSCLC, contingent on mutation ...
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 ...
A: No new regulations were published in 2025 specific to data integrity. The evolving global regulatory systems do, however, ...
The companies have extended a commercial supply partnership for the manufacture of Sohonos (palovarotene), which is a ...
Innovators are increasingly focused on whether outsourced partners can help them make better decisions earlier, before ...
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