PERSON
FDA Advisory Panel Rejects GSK’s Blenrep in New Combinations Over Safety, Efficacy Concerns
Blenrep; GSK; FDA Advisory Panel; multiple myeloma; ocular toxicity; safety concerns; DREAMM trials; drug approval; relapsed or refractory multiple myeloma
BioNTech Chief Strategy Officer Departs Amid Oncology Pivot and Major Deals
BioNTech; chief strategy officer; Ryan Richardson; oncology pivot; CureVac acquisition; cancer pipeline; leadership transition
Pfizer Warns of ‘Near-Term Stock Out’ of Penicillin Used for Treating Syphilis in Pregnant Women After Recall
Pfizer; penicillin recall; Bicillin L-A; syphilis treatment; pregnant women; drug shortage; congenital syphilis; FDA; Extencilline; public health
CDER Employees Leave FDA in Droves Amid HHS Overhaul
CDER; FDA; HHS overhaul; employee resignations; layoffs; health policy; restructuring; Robert F. Kennedy Jr.
RFK Jr. Removes Top HHS Aides in Major Leadership Shakeup
RFK Jr.; Health and Human Services; leadership reshuffle; chief of staff; Matt Buckham; Heather Flick Melanson; Hannah Anderson; Trump loyalists; policy shakeup
RFK Jr. Fires Top HHS Leadership in Major Department Shakeup
RFK Jr.; HHS; leadership shakeup; chief of staff replaced; Heather Flick Melanson; Hannah Anderson; Matt Buckham; health policy; White House liaison
RFK Jr. Reshuffles Top HHS Leadership, Replacing Chief of Staff and Deputy Chief
RFK Jr.; HHS; leadership shakeup; chief of staff; Heather Flick Melanson; Hannah Anderson; Matt Buckham; staff changes; federal health policy
Vertex, NHS England Finalize Reimbursement Deal for CF Drug Alyftrek
Vertex; NHS England; Alyftrek; cystic fibrosis; reimbursement agreement; triple therapy; CFTR gene mutation; NICE; UK healthcare
Veru Survey Highlights Muscle Loss Concerns Among GLP-1 Users as Lean Mass-Preserving Drug Advances
Veru; GLP-1 receptor agonists; muscle loss; enobosarm; lean mass; obesity; survey; older adults; high-protein diet
FDA Chief Calls for Lower User Fees as PDUFA VIII Negotiations Begin
FDA; user fees; PDUFA VIII; regulatory policy; drug approval; fee structure; negotiations