The month’s FDA approvals: what got cleared, why it matters, and the commercial signals investors should care about.
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Make us preferred on GoogleZidesamtinib produced responses in 44% of 117 patients who had already taken a ROS1 inhibitor, and in 48% of those with measurable brain metastases.
Enlicitide cut LDL-C by 56% against placebo in a 2,904-patient trial, putting PCSK9 inhibition into a once-daily tablet.
Gedatolisib plus fulvestrant and palbociclib reached 9.3 months median progression-free survival against 2.0 on fulvestrant alone.
Atacicept cut proteinuria by 42% against placebo at week 36, though accelerated approval leaves open whether it preserves kidney function.
New options emerged in MRI contrast imaging, complicated urinary tract infections, and thyroid eye disease.
Veligrotug produced a proptosis response in 70% of patients with active disease and 57% with chronic disease at week 15.
Tebipenem pivoxil was non-inferior to intravenous imipenem-cilastatin in hospitalized patients, at 58.5% against 60.2% on the composite response.
Gadoquatrane binds four gadolinium centers to one molecule, and is approved down to term neonates at 0.04 mmol of gadolinium per kilogram.
New options emerged in ESR1-mutated breast cancer, mantle cell lymphoma, uncontrolled hypertension, hepatitis delta, and complicated urinary tract infections.
Ensitrelvir cut symptomatic infection among household contacts from 9.0% to 2.9%, and is approved in the US for prevention only.
Cefepime-zidebactam cured 89% of complicated urinary tract infections against meropenem's 68%, and arrives from an Indian discovery program.
Pivekimab sunirine put 69.7% of untreated patients into remission, against 15.7% of those with relapsed or refractory disease.
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.
Baxdrostat lowered systolic pressure by a placebo-adjusted 9.8 mmHg in patients already taking at least two antihypertensives including a diuretic, targeting the aldosterone pathway behind much of resistant hypertension.
Sonrotoclax produced responses in 52% of 103 previously treated patients in a single-arm trial, with a median duration of 15.8 months.
Vepdegestrant more than doubled median progression-free survival against fulvestrant in ESR1-mutated advanced breast cancer, at 5.0 months against 2.1.
London · 15–19 November 2026
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