Summit’s Ivonescimab Delivers First Major PFS Win in EGFR-Mutated Lung Cancer After TKI Failure
HARMONi Phase 3 results in The Lancet Oncology show ivonescimab + chemo cuts progression risk nearly in half for post-TKI EGFR-mutated NSCLC.
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Guardant Health Ordered to Pay Over $245 Million in DNA Sequencing Patent Dispute
Court orders Guardant Health to pay over $245.2M for willfully infringing TwinStrand’s DNA sequencing patents. Ongoing 6% royalties apply; Guardant will appeal.
Capricor Gets Three Extra Months as FDA Reviews Stronger Upper-Limb Data for Deramiocel
FDA extends Capricor’s Deramiocel BLA review to Nov 22, 2026 after new 24-month HOPE-3 data focused on upper limb function in Duchenne MD.
Vanda Pharmaceuticals Receives First EU Orphan Designation for Imsidolimab in Generalized Pustular Psoriasis
Vanda Pharmaceuticals receives the first EU orphan designation for imsidolimab to treat rare, life-threatening GPP. FDA decision due Dec 12, 2026.
FDA Places Clinical Hold on REGENXBIO’s Gene Therapy for Hunter Syndrome
FDA places clinical hold on REGENXBIO’s RGX-121 for Hunter Syndrome after asymptomatic spine MRI findings in 5 patients. Patients remain well; no near-term BLA resubmission.
Alvotech Partners with Lotus on Biosimilars to Imfinzi and Hemlibra in the US and Asia
Alvotech partners with Lotus for biosimilars to Imfinzi and Hemlibra in the US and Asia. Deal worth up to $150M plus ongoing supply revenue.