fda-and-biotech News
Valneva Shares Climb on Positive Lyme Disease Vaccine Booster Data
Biotech firm and partner Pfizer report strong immune response in Phase 2 trial, bolstering prospects for the first human vaccine against the tick-borne illness in two decades.
Verrica Shares Surge After Insiders Snap Up $17.9M Stake
Stock jumps over 8% as director and CEO lead a major investment in a $50 million private placement, signaling strong confidence in the biotech's pipeline.
Ascendis Pharma Shares Dip on FDA Delay for Key Dwarfism Drug
The U.S. regulator has extended the review period for TransCon CNP by three months, pushing a potential approval to late February 2026 and creating uncertainty for a cornerstone of the company's growth strategy.
Kura Oncology Drug Added to Key US Cancer Guidelines
KOMZIFTI's inclusion in the influential NCCN guidelines for AML is expected to accelerate commercial adoption following its recent FDA approval.
Arrowhead Pharma Surges 6% on Blockbuster Revenue, First FDA Approval
Shares hit a 52-week high after the company reported a massive $829M in revenue from partnerships and secured FDA approval for its first drug, REDEMPLO.
Scilex Holding Soars After Securing $20.3 Million in Warrant Deal
The biopharmaceutical firm's shares jumped after it shored up its balance sheet, but the deal introduces new shareholder dilution concerns.
Autolus Surges 12% on Key UK Recommendation for Leukemia Drug
NICE backs CAR-T therapy Aucatzyl, paving the way for NHS reimbursement and an imminent commercial launch in England and Wales.
J&J Halts Alzheimer's Trial, But Shares Shrug Off Setback
The healthcare giant discontinued its Phase 2b study for posdinemab after the anti-tau drug failed to show efficacy, highlighting the immense challenges in Alzheimer's research.