FDA approvals - June 2026
New options emerged in MRI contrast imaging, complicated urinary tract infections, and thyroid eye disease.
22 stories
Make us preferred on GoogleNew options emerged in MRI contrast imaging, complicated urinary tract infections, and thyroid eye disease.
New options emerged in ESR1-mutated breast cancer, mantle cell lymphoma, uncontrolled hypertension, hepatitis delta, and complicated urinary tract infections.
The first-in-class entry inhibitor cleared a 48%-versus-2% Week 48 virologic and biochemical response — reaching US patients three years after the FDA turned down the original 2 mg dose.
Dr. Adil Ali asks Dr. John Patton (CSO) and Dan Miller (Formulation Development Lead) all about eSpraye's drug pipeline.
New options emerged in PBC-associated itch, plaque psoriasis, neurologic Hunter syndrome, and platinum-resistant ovarian cancer.
Copper replacement formalizes care for a fatal pediatric metabolic disorder.
The winter batch of FDA approvals featured therapies that compress intervention into fewer doses, fewer visits, and fewer points of failure.
Mitochondrial disease and mutant leukemias signal where specialty pharma is placing its biggest bets.
Scarred lungs and hot flashes are two FDA wins for specialty pharma.
With a median progression-free survival nearing four years in ROS1 lung cancer, Nuvation Bio’s breakthrough therapy signals a turning point for precision oncology - validating Dr. David Hung’s patient-first vision.
September’s FDA approvals signaled shifting rules in biopharma - faster launches, smarter formulations, and bold plays from rising innovators and the familiar giants.
“Fifteen to twenty years ago, a woman under 35 had a 20% chance of live birth per IVF cycle. At Kindbody, today, it’s greater than 50%,” David Stern credits lab innovation and AI for rewriting fertility’s odds.
“Preventative care spending fell from 14.1% to just 5.2% of Government healthcare spending.” Ben Phillips warns that welfare reforms could widen existing health gaps.
Anis Fahandej-Sadi breaks down the big problems with current incentive structures
All the details on when the 44th annual J.P. Morgan Healthcare Conference takes place!
London · 15–19 November 2026
Explore Onyx’s independent guide to the events and make the most of your week in London.