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.
Novo Nordisk HRS-1596 is the focus of a new exclusive license with Hengrui Pharma worth up to $2.6 billion, including $300 million upfront. The phase 1-ready GLP-1/GIP dual agonist has potential for once-weekly oral dosing.
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Merck and Daiichi Sankyo have voluntarily withdrawn the U.S. Biologics License Application for ifinatamab deruxtecan in certain patients with previously treated extensive-stage small cell lung cancer after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.
Novo has secured a positive CHMP opinion for FREHEMGO® (denecimig) to treat haemophilia A in adults and children, offering the first FVIIIa mimetic with once-monthly, bi-weekly, and weekly dosing options in a pre-filled pen.
The FDA has approved a label update cutting Amgen IMDELLTRA monitoring time for the first two doses from 22-24 hours to 6-8 hours, a change aimed at easing treatment burden for ES-SCLC patients in community oncology settings.
The FDA has granted Priority Review to Roche’s Enspryng (satralizumab) for MOGAD, a rare autoimmune CNS disease with no approved treatments, after Phase III METEOROID data showed a 68% relapse risk reduction.
AstraZeneca’s Etcamah (camizestrant) has won US FDA approval alongside CDK4/6 inhibitors for HR-positive, HER2-negative breast cancer patients who develop an ESR1 mutation before disease progression.
Abbott Libre Duo 10 Day has received FDA authorization as the world’s first dual glucose-ketone biowearable, designed to alert people with diabetes to rising DKA risk while tracking glucose in real time.
