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 ...
FDA enforcement accelerated, with recent warning-letter volume exceeding the prior decade’s total, signaling a sustained departure from historical, reactive promotional oversight. “Sameness” ...
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%.
M capital investment will retrofit a 45‑acre Athlone site for high-volume oral GLP‑1 tableting, with phased completion in 2027–2028 to de-risk CMC supply. Designating Athlone as a primary ex-US ...
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 ...
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 ...
A: No new regulations were published in 2025 specific to data integrity. The evolving global regulatory systems do, however, ...
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 ...
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