Akeso’s gumokimab enters NMPA review for ankylosing spondylitis after Phase 3 success. Find out what this could mean for IL-17 therapies in China.
Find out how iRegene’s iPSC-based Parkinson’s therapy NouvNeu001 became the first to earn both RMAT and Fast Track status from the FDA.
AbbVie’s Phase 3 epcoritamab data raise critical questions about survival endpoints and bispecific antibodies in relapsed lymphoma. Read the full analysis.
Harbour BioMed acquires stake in Spruce Biosciences, reinforcing its SPR202 collaboration. Find out what this signals for CRH-targeted therapies.
AstraZeneca takes full control of a GPC3 CAR-T therapy for liver cancer. Find out what this deal changes and what risks still loom.
D3 Bio secures U.S. FDA IND clearances for two KRAS programs, advancing G12D monotherapy and G12C resistance combo trials. See what this means for oncology.
Organon’s etonogestrel implant NEXPLANON has received FDA approval for extended use up to five years, marking a significant regulatory win for the women’s health–focused pharmaceutical company. The decision, which comes via a supplemental new drug application (sNDA), builds on existing data supporting the implant’s high efficacy and safety profile and broadens its potential utility among […]
Find out how ImmunityBio’s CD19 CAR-NK cell therapy may change treatment for Waldenström lymphoma with durable responses and no chemotherapy.
FDA approves NEXPLANON for five years of use with REMS program. Find out how this reshapes contraceptive access, safety, and policy impact.
Repare shareholders approve XenoTherapeutics deal. Find out how this nonprofit acquisition could reshape oncology pipeline models.