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FDA
Pazdur To Retire Weeks After Taking On Coveted FDA Role
Newly appointed Center for Drug Evaluation and Research director Richard Pazdur has filed retirement papers with the agency—three weeks after accepting the role—amid clashes with Commissioner Marty Makary over certain FDA programs.
December 2, 2025
·
3 min read
·
Heather McKenzie
Regulatory
Experts Decry Prasad Memo’s Lack of Transparency as Vaccine Stocks Dip
With no evidence to support the claim that 10 children died due to COVID-19 vaccines, experts unpack the impact of CBER chief Vinay Prasad’s leaked vaccine memo.
December 2, 2025
·
4 min read
·
Dan Samorodnitsky
Brain cancer
Imvax Heads to FDA With 6-Month Survival Gain in Glioblastoma, Despite Endpoint Miss
While Imvax’s autologous immunotherapy IGV-001 missed the primary endpoint of progression-free survival in a Phase IIb trial, the company will request a meeting with the FDA to discuss next steps for “synergistic” treatment.
December 2, 2025
·
2 min read
·
Dan Samorodnitsky
Alzheimer’s disease
I Remember Aduhelm. The Return of Roche in Alzheimer’s Is a Turning Point
After covering the Alzheimer’s space through every high and low,
BioSpace
’s Annalee Armstrong welcomes back Roche for the 2026 Alzheimer’s Renaissance.
December 2, 2025
·
2 min read
·
Annalee Armstrong
Alzheimer’s disease
Roche Is Back in Alzheimer’s as Latest Antibody Clears Amyloid Plaques
Trontinemab lowered amyloid levels below the threshold of positivity in 92% of treated patients.
December 2, 2025
·
2 min read
·
Tristan Manalac
Vaccines
ACIP To Discuss Hep B, Childhood Vaccine Schedule Under New Chair Who Linked COVID Shots to Cancer
This week’s meeting of the Advisory Committee on Immunization Practices will be led by Kirk Milhoan, a physician and pastor who recently claimed that COVID-19 vaccines contained a contamination that causes cancer.
December 2, 2025
·
2 min read
·
Tristan Manalac
Press Releases
QurAlis to Present Data From its Phase 1 Clinical Trial of QRL-101, a Potential Best-in-Class Selective Kv7.2/7.3 Ion Channel Opener, at American Epilepsy Society 2025 Annual Meeting
December 2, 2025
·
2 min read
Press Releases
enGene’s Detalimogene Selected for FDA Manufacturing Pilot Program to Support Manufacturing Readiness
December 2, 2025
·
9 min read
Press Releases
Arrowhead Pharmaceuticals Receives FDA Breakthrough Therapy Designation for Plozasiran in Severe Hypertriglyceridemia
December 2, 2025
·
7 min read
Press Releases
BriaCell to Present Phase 2 Survival & Phase 3 Clinical Data at SABCS® 2025
December 2, 2025
·
4 min read
1 of 86,571
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