Featured
FDA New Drug
Approvals
2026
13
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Pierre Fabre / Atara
Tabelecleucel (Ebvallo)
EBV+ Post-Transplant Lymphoproliferative Disease
CRL
Aquestive Therapeutics
Anaphylm (dibutepinephrine)
Anaphylaxis
CRL
REGENXBIO
RGX-121 (clemidsogene)
Hunter Syndrome (MPS II)
CRL
Aldeyra Therapeutics
Reproxalap
Dry Eye Disease
CRL
Vanda Pharmaceuticals
Tradipitant
Gastroparesis
CRL
FDA Season 2026 — Scorecard
Pierre Fabre / Atara
Tabelecleucel (Ebvallo)
EBV+ Post-Transplant Lymphoproliferative Disease
Aquestive Therapeutics
Anaphylm (dibutepinephrine)
Anaphylaxis
REGENXBIO
RGX-121 (clemidsogene)
Hunter Syndrome (MPS II)
Aldeyra Therapeutics
Reproxalap
Dry Eye Disease
Vanda Pharmaceuticals
Tradipitant
Gastroparesis
Exclusive Interviews
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Aspect Biosystems plans clinical data in 2027 from cell therapy pipeline, CEO says at Meeting on the Mesa
Tamer Mohamed told Cell & Gene Meeting on the Mesa that Aspect Biosystems plans to generate clinical data in 2027, and set out preclinical data for its adrenal insufficiency and type 1 diabetes programs.
Jason Jones, Head of Global Business Development, Cellular Origins | Onyx Live | ISCT Dublin 2026
Cell and gene therapy can get treatments approved – scaling them is the hard part. Cellular Origins' Jason Jones on automating manufacturing to reach 100,000 patients a year.
Prostate screening could be some men’s only NHS touchpoint in years. With public role models shifting stigma, it should be treated as early detection and a route back into routine care.
The story of how an Indian biotech startup slashed the cost of CAR-T from $475,000 to just $30,000 and started a revolution in global CAR-T therapy access.
“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
"Almost a third of over-65s will fall each year," but could nGVS represent a discreet tool against imbalance?
To live in the grey zone of sub-clinical pathology is to be unwell enough to hurt, but not enough to be heard.
First-generation medical students carry two textbooks - one devoted to anatomy, the other towards cultivating resilience.
Trillions of microbes inside us are not mere bystanders, but quiet architects of our moods.
"These projects are more than acts of goodwill," China's Health Silk Road is as much about soft power as it is about medicine.
“Pain is treated like a badge of honor" in medicine, but the cost is a workforce breaking under invisible pressure.
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 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 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 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.
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.
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.
FDA approves Merck's Idvynso, a doravirine and islatravir tablet, four years after a clinical hold on islatravir
Doravirine and islatravir matched Biktarvy in a switch trial, with the islatravir dose cut to 0.25 mg after a 2021 clinical hold.
Kim Brown, CEO, Compass Biomedical | Onyx Live | ISCT Dublin 2026
Everyone watches the final cell therapy – far fewer watch what the cells are grown in. Compass Biomedical's Kim Brown on why culture media quietly shapes the product.
Jason Jones, Head of Global Business Development, Cellular Origins | Onyx Live | ISCT Dublin 2026
Cell and gene therapy can get treatments approved – scaling them is the hard part. Cellular Origins' Jason Jones on automating manufacturing to reach 100,000 patients a year.
Dimitrios Kouroupis, Professor, University of Miami | Onyx Live | ISCT Dublin 2026
Exosomes are "cell therapy without the cells" – and University of Miami's Dimitrios Kouroupis sees these cell-free vesicles reshaping musculoskeletal medicine.
Jon Ellis, CEO, Trenchant BioSystems | Onyx Live | ISCT Dublin 2026
Fewer than 10% of eligible CAR-T patients ever get treated. Trenchant BioSystems CEO Jon Ellis says the bottleneck is no longer the science – it's manufacturing.
Sean Werner, CTO, BioLife Solutions | Onyx Live | ISCT Dublin 2026
Most cell therapies arrive at the patient frozen – and BioLife Solutions CTO Sean Werner says the field still treats what happens after manufacturing as an afterthought.
Augustin de Bettignies, Chief Business Officer, MPC Therapeutics | Onyx Live | ISCT Dublin 2026
Most of cell therapy fixates on the cell's target. MPC Therapeutics' Augustin de Bettignies says its metabolism — what it burns during manufacturing — matters just as much.
Clene Nanomedicine's ALS drug is a gold nanocrystal you drink. It missed its primary endpoint. The FDA is still listening.
CEO Rob Etherington and chief scientist Mark Mortenson on the bioenergetic thesis behind CNM-Au8, the HEALEY data, and five meetings with the agency.
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.
Slone Partners’ Leslie Loveless on the post-boom talent reset in biopharma
Biopharma’s boom-era org charts are giving way to leaner, faster operating models. Slone Partners CEO, Leslie Loveless, says the edge now goes to pragmatic builders: “The companies that win right now are hiring leaders who can do more with less.”
A world-expert in Stargardt disease has developed a pill to slow vision loss: why Tinlarebant could win FDA approval
After years studying Stargardt’s natural history, Belite Bio’s Dr. Hendrik Scholl is championing Tinlarebant as a practical early intervention - “Intervention is simply one pill a day - and we are able to slow down the progression of disease by more than one-third.”
Belite Bio concludes phase 3 Stargardt trials with nearly 40% retinal cell preservation
Belite is positioning Tinlarebant for regulatory submission after Phase 3 Stargardt data, emphasizing the long-term safety burden of a systemic, lifelong oral therapy: “For a lifelong treatment, the safety bar is about as high as it gets.”
Why Flatiron is betting on data quality, not hype, to power the next era of cancer care
With global oncology scale and nearly 2,000 scientific publications, Flatiron Health is positioning itself as the industry’s most trusted evidence partner by pairing AI-driven speed with uncompromising scientific rigor. “We don’t chase hype. We build trust, and in healthcare that’s non-negotiable.”
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