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.
Waskyra’s FDA and EMA approvals spotlight AGC Biologics’ rare disease manufacturing model. Find out what this means for future nonprofit-led therapies.
Genmab’s epcoritamab improved PFS in a Phase 3 DLBCL trial. Find out how this could reshape bispecific monotherapy in aggressive B-cell lymphoma care.
Autobahn’s elunetirom may offer a novel neuroplasticity-driven treatment for depression. Find out what its latest data mean for the future of MDD therapy.
Atossa Therapeutics Inc. has received Orphan Drug Designation from the U.S. Food and Drug Administration for its investigational compound (Z)-Endoxifen in the treatment of Duchenne muscular dystrophy (DMD). The designation, disclosed on January 16, 2026, supplements the previously granted Rare Pediatric Disease Designation for the same compound and indication. The move marks a notable regulatory
Find out how ImmunityBio’s subcutaneous immunotherapy ANKTIVA secured Saudi approval for NSCLC and what it means for global immuno-oncology.
Dr. Reddy’s launches first U.S. generic of Pataday 0.7% eye drops. Find out what this means for the OTC allergy market and Novartis’s branded edge.