Curated news and analysis on clinical trials, drug approvals, and medical research.
Vir Biotechnology reported Q4 EPS of ($0.31), beating estimates by $0.23, with revenue of $64.07 million. The company announced a global strategic collaboration with Astellas for VIR-5500 and reported $781.6 million in cash and investments.
Novo Nordisk's next-generation obesity drug CagriSema achieved 23% weight reduction compared to 25.5% for Eli Lilly's tirzepatide in an 84-week trial, causing Novo shares to fall 15% and raising questions about its competitive position.
Vir Biotechnology announced a global strategic collaboration with Astellas for VIR-5500, a PSMA-targeted dual-masked T-cell engager for prostate cancer, and reported $781.6 million in cash and investments as of December 31, 2025.
The FDA's Center for Biologics Evaluation and Research issued a refusal-to-file letter to Moderna for its investigational influenza vaccine mRNA-1010, citing concerns over the Phase 3 trial control arm and whether it reflected the best-available standard of care.
New research demonstrates that dexamethasone effectively ameliorates cytokine-release syndrome in CAR T-cell therapy for multiple myeloma while maintaining or enhancing anti-tumor activity and increasing CAR T-cell levels.
Health systems are learning that successful cell and gene therapy programs require early pharmacy involvement, strong payer partnerships, and flexible infrastructure to navigate complex contracts, workflows, and financial realities.
DNA from a glove found near Nancy Guthrie's home did not match FBI database records. The investigation into the 84-year-old's disappearance has entered its third week with no leads from the DNA evidence.
The FDA issued draft guidance establishing a plausible mechanism framework for approving individualized therapies targeting ultra-rare diseases when randomized controlled trials are not feasible due to small patient populations.
Ralph Abraham resigned as CDC principal deputy director after less than two months, leaving the agency's top two positions vacant. The departure is part of broader HHS leadership changes under Secretary Robert F. Kennedy Jr.
The FDA reversed its decision to reject Moderna's mRNA influenza vaccine application, accepting it for review one week after an initial refusal-to-file that reportedly involved senior leaders overruling staff advice.
The FDA has proposed new guidelines to create a pathway for approving bespoke therapies tested in small patient groups, specifically targeting rare genetic conditions and gene editing treatments that don't fit traditional approval systems.
The FDA accepted a new drug application for tirabrutinib to treat relapsed or refractory primary central nervous system lymphoma, with a decision expected December 18, 2026. The application is supported by phase 2 trial data showing a 67% overall response rate.
Faron Pharmaceuticals announces acceptance of bexmarilimab Phase I/II data for poster presentation at BSH 2026, while launching a new Phase II BEAM-X study evaluating the drug in AML patients post-stem cell transplantation.
The FDA released draft guidance establishing a new approval framework for individualized gene-editing and RNA-based therapies targeting ultra-rare diseases, allowing approvals based on small studies when traditional trials are not feasible.
AIM ImmunoTech outlined key milestones for its Phase 2 DURIPANC trial evaluating Ampligen combined with durvalumab in metastatic pancreatic cancer, with primary endpoint evaluation expected in December 2026.
T-cell immunotherapies including CAR T-cell therapy and T-cell engagers are expanding cancer treatment options but present significant cardiovascular risks and operational complexities requiring coordinated multidisciplinary management.
Rocket Pharmaceuticals will participate in two investor conferences in March 2026, with the CEO taking part in a fireside chat and management hosting investor meetings at both events.
Federal regulators unveiled a new regulatory approach to accelerate approval of personalized genetic treatments for rare, life-threatening conditions, allowing smaller studies when traditional large-scale trials aren't practical while maintaining post-market safety oversight.
ImmunityBio announced $113 million in net product revenue for Anktiva in 2025, a 700% year-over-year increase, while expanding regulatory authorization to 33 countries and securing first approval for lung cancer treatment in Saudi Arabia.
The FDA proposed a new framework to accelerate approvals of personalized treatments for rare genetic diseases, allowing drugmakers to rely on small studies when traditional trials are not feasible while requiring post-approval evidence collection.
