ME Therapeutics' Salim Dhanji on making the patient's body the bioreactor
The Vancouver immunologist on myeloid cells as a delivery route, STING for cold tumours, and why in vivo CAR could land near the price of a checkpoint inhibitor.
Drug Discovery
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Creasallis' Zahra Jawad on why US investors said yes before Cambridge did
The Cambridge founder on re-engineering antibodies to break into solid tumours, raising a seed round without a professor behind her, and why hiring in the UK is her hardest problem.
The primal blueprint: how CamMed mimics evolution to reinvent self-amplifying RNA
CamMed CEO Dr. Ahmet Can Berkyurek on an AI-discovered, single-protein replicase drawn from biology's most ancient machinery — and his case for building it in the UK
FDA approves GSK's Jideytro for ROS1-positive lung cancer, a week after the Nuvalent acquisition closed
Zidesamtinib produced responses in 44% of 117 patients who had already taken a ROS1 inhibitor, and in 48% of those with measurable brain metastases.
FDA approves Merck's Lipfendra, a once-daily oral PCSK9 inhibitor for lowering LDL cholesterol
Enlicitide cut LDL-C by 56% against placebo in a 2,904-patient trial, putting PCSK9 inhibition into a once-daily tablet.
FDA approves Celcuity's Revtorpyk for PIK3CA wild-type breast cancer after CDK4/6 failure
Gedatolisib plus fulvestrant and palbociclib reached 9.3 months median progression-free survival against 2.0 on fulvestrant alone.
FDA grants Vera's Trutakna accelerated approval to reduce proteinuria in IgA nephropathy
Atacicept cut proteinuria by 42% against placebo at week 36, though accelerated approval leaves open whether it preserves kidney function.
FDA approvals - June 2026
New options emerged in MRI contrast imaging, complicated urinary tract infections, and thyroid eye disease.
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.
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.
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.
FDA approvals - May 2026
New options emerged in ESR1-mutated breast cancer, mantle cell lymphoma, uncontrolled hypertension, hepatitis delta, and complicated urinary tract infections.
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.
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.
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.
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.
