NIH launches national cancer vaccine initiative, its next "big bet", sparking biotech rally
The NIH's planned national cancer vaccine push lifted Moderna and other biotech shares and renewed attention to mRNA-based cancer vaccines.
Benzinga · +7 outlets
Moderna stock surges to 4-year high on Nasdaq-100 inclusion and cancer vaccine hopes
Moderna shares jumped as the company prepared to join the Nasdaq-100 and investors bet on its cancer vaccine pipeline.
Stocks Down Under · +14 outlets
FDA flags four deaths in Newron schizophrenia drug studies
Regulators cited a safety signal after four patient deaths in trials of Newron's experimental schizophrenia drug.
Reuters · +8 outlets
Teva wins FDA approval for Weltruza, first once-monthly subcutaneous olanzapine for schizophrenia
The long-acting injectable offers a monthly subcutaneous option for adults with schizophrenia without added pills or post-injection monitoring.
Teva Pharmaceuticals · +14 outlets
Argenx drops Vyvgart Sjogren's trial after futility signal, offsetting celiac win
A monitoring board recommended stopping the Phase 3 Sjogren's study for futility, a setback for the company's blockbuster expansion plans.
Biopharmadive · +4 outlets
FDA review documents on Revolution Medicines' Rasonque spark sell-off over KRAS data
Newly disclosed FDA review documents suggested the drug may not be as broadly effective as investors had assumed.
Biopharmadive · +3 outlets
Hospitals sue again to halt Trump administration's 340B rebate pilot
The AHA is challenging a plan to convert the federal drug discount program from upfront discounts to after-the-fact rebates.
STAT · +9 outlets
FDA approves Asahi Kasei drug for persistent herpes infections
The approval adds a new treatment option for persistent herpes infections.
Reuters · +7 outlets
Pfizer's Tukysa gains first-line approval in HER2-positive breast cancer maintenance
The FDA cleared Tukysa for first-line use in HER2-positive breast cancer, widening the drug's label.
Fierce Pharma · +13 outlets
FDA withdraws Zepzelca approval for previously treated small cell lung cancer
The withdrawal removes an accelerated approval for the drug in pretreated small cell lung cancer.
Cure Today · +5 outlets
FDA approves atezolizumab for stage III dMMR colon cancer after ATOMIC trial
The decision follows the landmark ATOMIC trial supporting immunotherapy in this earlier-stage colon cancer setting.
Bioengineer.org · +14 outlets
Viatris to buy Pacira for $1.7B, adding non-opioid pain drugs
The deal hands Viatris two pain treatments with nearly $700 million in 2025 sales that face looming patent losses.
Biopharmadive · +4 outlets
HHS launches plan to strengthen vaccine injury research and reporting
The initiative, led by vaccine skeptic Robert F. Kennedy Jr., involves a new NIH clinic, updated monitoring and reimbursements for reporting suspected side effe
Biopharmadive · +13 outlets
Life Biosciences reports first glaucoma patients dosed with cellular reprogramming drug
Three glaucoma patients received a single injection of the experimental drug with no serious adverse events reported.
STAT · +14 outlets
TRex Bio prices $117M IPO to fund immune drug work
Eli Lilly is the largest equity holder in the company, which develops drugs that activate Treg cells to treat immunological conditions.
Biopharmadive · +2 outlets
Everest Medicines hires two former Moderna cancer vaccine scientists to build US mRNA pipeline
The Chinese biotech is recruiting veteran mRNA cancer vaccine researchers to accelerate global clinical development.
Menafn · +4 outlets
Steven Quay no longer in consideration for top NIAID infectious disease role
The biopharma executive, a leading lab leak theorist with no infectious disease background, was dropped from consideration to lead NIAID.
STAT
Ultragenyx to sell rare pediatric disease priority review voucher for $210 million
The voucher sale gives the company a much-needed cash infusion.
Biopharmadive