fda-and-biotech News
Incyte Shares Rise on EU Approval for Lymphoma Drug Minjuvi
The European Commission has greenlit the treatment for adult patients with relapsed or refractory follicular lymphoma, a hard-to-treat cancer.
J&J Gains FDA Approval for Faster-Acting Lung Cancer Therapy
The new subcutaneous version of Rybrevant, for use in a first-line combination therapy, significantly cuts administration time for patients with a common form of lung cancer.
Insmed Stock Slides After Brensocatib Nasal Polyp Trial Fails
The development setback for a secondary indication tempers pipeline hopes, even as the company pivots with a new cancer drug acquisition.
Immuneering Stock Surges on FDA, EMA Alignment for Pivotal Cancer Trial
The biotech firm secured regulatory agreement to advance its lead drug, atebimetinib, into a Phase 3 study for pancreatic cancer, a significant de-risking milestone.
Vistagen Shares Tumble as Anxiety Drug Fails Phase 3 Trial
The company's lead drug candidate, Fyxola, did not meet its primary endpoint in a pivotal late-stage study for social anxiety disorder, creating a major setback.
Moleculin Rises on Promising Pediatric Brain Tumor Drug Data
Phase 1 trial of WP1066 shows positive safety and early anti-tumor signals in children with highly aggressive, recurrent brain cancers where few treatments exist.
Rezolute Stock Plummets 90% on Failed Drug Trial
Phase 3 study of lead drug candidate RZ358 for a rare pediatric disease fails to meet primary goals, erasing over $1 billion in market value.
Solid Biosciences Soars on U.S. Newborn Screening Panel Decision
HHS adds Duchenne muscular dystrophy to its recommended universal screening panel, vastly expanding the addressable market for gene therapies.