FDA approves Viridian's Lumvoa for thyroid eye disease in both active and chronic disease
Veligrotug produced a proptosis response in 70% of patients with active disease and 57% with chronic disease at week 15.
Published 26 Jun 2026
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FDA approves GSK's Utebzi, an oral antibiotic for complicated urinary tract infections with few alternatives
Tebipenem pivoxil was non-inferior to intravenous imipenem-cilastatin in hospitalized patients, at 58.5% against 60.2% on the composite response.
Published 17 Jun 2026
FDA approves Bayer's Ambelvist, an MRI contrast agent with a lower gadolinium dose
Gadoquatrane binds four gadolinium centers to one molecule, and is approved down to term neonates at 0.04 mmol of gadolinium per kilogram.
Published 12 Jun 2026
FDA approvals - May 2026
New options emerged in ESR1-mutated breast cancer, mantle cell lymphoma, uncontrolled hypertension, hepatitis delta, and complicated urinary tract infections.
Published 2 Jun 2026
FDA approves Shionogi's Xocova, an oral antiviral for preventing COVID-19 after exposure
Ensitrelvir cut symptomatic infection among household contacts from 9.0% to 2.9%, and is approved in the US for prevention only.
Published 29 May 2026
FDA approves Wockhardt's Zaynich, an intravenous antibiotic for complicated urinary tract infections
Cefepime-zidebactam cured 89% of complicated urinary tract infections against meropenem's 68%, and arrives from an Indian discovery program.
Published 29 May 2026
FDA approves AbbVie's Decnupaz, a CD123-directed antibody-drug conjugate, for blastic plasmacytoid dendritic cell neoplasm
Pivekimab sunirine put 69.7% of untreated patients into remission, against 15.7% of those with relapsed or refractory disease.
Published 27 May 2026
FDA approves Gilead's Hepcludex as the first treatment for chronic hepatitis delta
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.
Published 22 May 2026
FDA approves AstraZeneca's Baxfendy, an aldosterone synthase inhibitor for uncontrolled hypertension
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.
Published 15 May 2026
eSpraye (Pulmonary fibrosis, Dry Powder) - Onyx Analyst
Dr. Adil Ali asks Dr. John Patton (CSO) and Dan Miller (Formulation Development Lead) all about eSpraye's drug pipeline.
Published 14 May 2026
FDA grants BeOne's Beqalzi accelerated approval in mantle cell lymphoma after a BTK inhibitor
Sonrotoclax produced responses in 52% of 103 previously treated patients in a single-arm trial, with a median duration of 15.8 months.
Published 13 May 2026
FDA approves Arvinas and Pfizer's Veppanu, a PROTAC protein degrader, in ESR1-mutated breast cancer
Vepdegestrant more than doubled median progression-free survival against fulvestrant in ESR1-mutated advanced breast cancer, at 5.0 months against 2.1.
Published 1 May 2026
Eric Schlumpf, President & CEO, Stuart Therapeutics | Onyx Live | JPM 2026
Stuart Therapeutics is testing the first collagen mimetic peptide for dry eye disease – a novel mechanism that produced Week 1 staining gains vs. vehicle greater than any reported result for an approved therapy in their recent Phase 3.
Published 30 Apr 2026
Stuart Lowe, Head of Advanced Therapies, TTP | Onyx Live | Advanced Therapies 2026
A single CAR-T dose still takes up to 33 days to manufacture, at $170,000–$220,000 per batch.
Published 30 Apr 2026
The sugar layer biotech forgot - and why Anomer Bio thinks small molecules can finally drug it
Co-founder and CEO Sophie James on modified monosaccharides, intracellular glycan processing, and a rare-disease-first route into fibrosis, oncology, and Alzheimer's.
Published 29 Apr 2026
Stuart Curbishley, Chief Development & Manufacturing Officer, adthera bio | Onyx Live | Advanced Therapies 2026
Stuart Curbishley on how adthera bio is tackling the biggest bottleneck in cell and gene therapy: getting therapies manufactured at scale.
Published 29 Apr 2026
