The FDA has expanded the TALZENNA XTANDI approval to men with HRR gene-mutated metastatic androgen pathway modulation-naïve or -sensitive prostate cancer. The decision rests on Phase 3 TALAPRO-3 data showing an estimated 52% reduction in the risk of radiographic progression or death.
Regeneron says the CHMP has recommended EU approval of an alternative Libtayo dosing schedule: 700 mg every six weeks after an initial 12-week regimen of 350 mg every three weeks. The opinion also supports an optional 15-30 minute infusion for eligible patients. The European Commission decision is expected in the coming months.
The FDA has approved Tecentriq and Tecentriq Hybreza with a fluoropyrimidine and oxaliplatin for adjuvant treatment of stage III dMMR colon cancer, based on the phase III ATOMIC trial.
The FDA has approved Tecentriq and Tecentriq Hybreza with a fluoropyrimidine and oxaliplatin for adjuvant treatment of stage III dMMR colon cancer, based on the phase III ATOMIC trial.
The Novartis Rhapsido FDA approval makes remibrutinib the first approved treatment for adults with symptomatic dermographism not controlled by H1 antihistamines. It builds on Rhapsido’s existing chronic spontaneous urticaria indication.
Eli Lilly announced the Jaypirca Approval on October 2, 2026, as the FDA cleared pirtobrutinib for adults with previously untreated CLL/SLL and no known 17p deletion.
The Roche fenebrutinib FDA filing has been accepted under priority review for relapsing and primary progressive multiple sclerosis. The application draws on the FENhance 1, FENhance 2 and FENtrepid Phase III studies.
AbbVie JUVMO (tavapadon) has received FDA approval as the first selective D1/D5 receptor agonist for adults with Parkinson’s disease. AbbVie expects U.S. availability in October 2026.
Merck and Daiichi Sankyo have voluntarily withdrawn the U.S. Biologics License Application for ifinatamab deruxtecan in certain patients with previously treated extensive-stage small cell lung cancer after discussions with the FDA indicated that the submitted data did not meet the requirements for accelerated approval.
Lilly Olumiant Alopecia Areata has received FDA approval for pediatric patients 12 and older, expanding treatment access based on Phase 3 BRAVE-AA-PEDS trial results showing substantial scalp hair regrowth in adolescents with severe alopecia areata.
