AstraZeneca reports five-year overall survival data from the ADAURA Phase 3 trial showing TAGRISSO (osimertinib) reduces the risk of death by 51% versus placebo in patients with resected EGFR-mutated Stage IB–IIIA non-small cell lung cancer.
Johnson & Johnson announces FDA approval of RYBREVANT® (amivantamab-vmjw) in combination with lazertinib for first-line treatment of adults with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations.
Bristol Myers Squibb announces FDA accelerated approval of ZENBEXUS™ (iberdomide) — the first CELMoD agent approved for multiple myeloma — in combination with daratumumab and dexamethasone, based on a 41% MRD-negative complete response rate in the Phase 3 EXCALIBER-RRMM trial.
Regeneron and Sanofi announce FDA approval of DUPIXENT® (dupilumab) as the first biologic approved for adults with uncontrolled COPD with type 2 inflammation, based on the BOREAS and NOTUS Phase 3 trials showing significant reduction in moderate-to-severe exacerbations.
Orum Therapeutics announces FDA clearance of its IND application for ORM-1153, a first-in-class CD123-GSPT1 degrader-antibody conjugate (DAC), with plans to initiate a Phase 1 study in relapsed/refractory AML and other hematologic malignancies by end of 2026.
Pulnovo Medical announces enrollment of the first two U.S. patients in its PULSE-LHD IDE clinical trial at Henry Ford Hospital, evaluating pulmonary artery denervation (PADN) for pulmonary hypertension associated with left heart disease — a condition affecting 65–80% of all PH cases with no currently approved therapy.
Biogen and Eisai announce FDA approval of a subcutaneous formulation of LEQEMBI (lecanemab-irmb) for early Alzheimer's disease, offering a more convenient at-home administration option for patients.
Pfizer announces FDA approval of Elrexfio (elranatamab-bcmm) for earlier lines of multiple myeloma treatment based on positive Phase 3 MagnetisMM-5 trial data showing superior progression-free survival.
Moderna announces FDA approval of its updated mRNA-1283 COVID-19 vaccine formulated to target the predominant circulating SARS-CoV-2 variants for the 2026–2027 season.
Merck announces FDA approval of KEYTRUDA (pembrolizumab) in combination with carboplatin and paclitaxel as first-line treatment for adults with primary advanced or recurrent endometrial cancer.
