Vertex Pharmaceuticals Inc VRTX shares are rising in extended trading Monday after the company announced positive interim results for one of its Phase 3 trials. Vertex Pharmaceuticals stock is trading ...

The FDA has accepted a Biologics License Application for imsidolimab to treat generalized pustular psoriasis, a rare inflammatory skin condition.

ImmunityBio (NASDAQ: IBRX), a commercial-stage immunotherapy company, today announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of its supplemental Biologics License ...

Treatments for Alzheimer disease agitation, focal segmental glomerulosclerosis, hematological malignancies, HIV-1, and obesity are under review.

LEGEND pivotal cohort update planned for a spring 2026 medical conference12-month complete response data from LEGEND pivotal cohort expected in 2H 2026Biologics License Application (BLA) submission ...

Following Positive Type B Meetings with the FDA, BLA Submission for TA-ERT for the Treatment of Sanfilippo Syndrome Type B (MPS IIIB) on Track for the Fourth Quarter of 2026Appoints Dale Hooks as ...

FDA's elevated meeting status signals transition from biomarker data discussions to Accelerated Approval discussionsOS ...

Integrating Asymchem’s Payload–Linker Facility to Provide End-to-End, One-Stop Services for Drug Conjugates ...

ImmunityBio stated that the application includes additional information requested by the FDA to support its supplemental BLA for papillary disease.

Data support potential of isaralgagene civaparvovec as a one-time, well tolerated and durable Fabry disease gene therapy to provide meaningful, multi-organ clinical benefits that could fundamentally ...

Data support potential of isaralgagene civaparvovec as a one-time, well tolerated and durable Fabry disease gene therapy to provide meaningful, ...