top of page
Profile
Join date: Jun 19, 2021
About
7 likes received
3 comments received
0 best answers
Posts (32)
Aug 28, 2026 ∙ 12 min
Scientists Found a Hidden Immune Organ Inside the Human Skull — What It Means for Brain Cancer Treatment and Regulatory Affairs
Scientists at Washington University School of Medicine in St. Louis have identified a **skull immune organ** — lymphoid structures inside the skull's bone marrow that act as first responders to brain disease. Published in *Nature* on 19 August 2026, the study shows microscopic channels carry antigens from the brain into skull marrow, where **T follicular helper cells** train **B cells** to fight threats, including glioblastoma, before distant lymph nodes react. Similar cells were found in...
21
0
Aug 25, 2026 ∙ 11 min
FDA's Streamlined Nonclinical Safety Guidance for Monoclonal Antibodies: What It Means for Regulatory Affairs Professionals in 2026
In December 2025, the US Food and Drug Administration (FDA) published draft guidance — "Monoclonal Antibodies: Streamlined Nonclinical Safety Studies" (Docket FDA-2025-D-4634) — recommending that sponsors of monospecific monoclonal antibodies (mAbs) can reduce or eliminate long-duration animal toxicology studies, including in nonhuman primates (NHPs), where a robust weight-of-evidence (WoE) risk assessment supports doing so. It affects any company developing single-target mAb therapeutics for...
43
0
Aug 19, 2026 ∙ 12 min
Overqualified but Under-Skilled: How PhDs and Postdocs Can Pivot Into Regulatory Affairs Careers
A PhD to regulatory affairs career change is one of the most viable moves available to scientists who find the academic job market unable to absorb them. Vitae's 2026 tracking data shows that although 91% of UK doctoral graduates are employed, 41% remain in higher education roles, 93% of which are on fixed-term contracts. Regulatory affairs offers permanent, well-paid, office-based roles that value scientific rigour — but PhDs typically lack the submission-specific skills (CTD structure,...
106
0
Entry to Regulatory
Admin
More actions
bottom of page
