fda-and-biotech News
NeoGenomics Gains as Natera Ends Appeal in Cancer Test Patent Feud
Natera's voluntary withdrawal of its appeal solidifies a key legal victory for NeoGenomics, clearing the path for the Q1 2026 U.S. launch of its RaDaR cancer detection test.
Kyverna Stock Skyrockets 52% on Positive Autoimmune Disease Trial Data
The clinical-stage biotech plans to seek FDA approval for its CAR T-cell therapy, miv-cel, after it showed significant promise in treating the rare neurological disorder Stiff Person Syndrome.
Sanofi Shares Hit by Double Setback for MS Drug Tolebrutinib
The French drugmaker's pivotal Phase 3 trial for one form of multiple sclerosis failed, while US regulators delayed a decision on another, jeopardizing a key pipeline asset.
Kyverna Awaits Landmark Data on CAR-T Therapy for Rare Disorder
Shares near 52-week high as investors anticipate results from the KYV-101 trial in Stiff Person Syndrome, a major test for the novel autoimmune approach.
Vaccine Stocks Face Headwinds as FDA Weighs 'Black Box' Warning
A potential top-tier safety label for COVID-19 shots is creating mixed pressure on shares of Pfizer, Moderna, and BioNTech as the agency reviews safety data.
Relay Therapeutics Stock Soars on Promising Breast Cancer Drug Data
Interim results for zovegalisib show 'robust activity' in a targeted patient group, leading to a Wells Fargo upgrade and a 52-week high for the biotech firm's shares.
ImmunityBio Shares Jump as Bladder Cancer Drug Wins Key EU Panel Nod
European Medicines Agency recommends conditional approval for Anktiva, paving the way for access to patients with a hard-to-treat form of the disease.
Amgen Secures FDA Nod for Uplinza in Crowded Myasthenia Gravis Market
The approval for the rare muscle disorder marks a key step in Amgen's rare disease strategy but places it in a competitive field with established rivals.