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FDA New Drug
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2026
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Onyx Season 2026 Scorecard
Exclusive Interviews
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Chris Hall, CEO, Personalis | Onyx Live | JPM 2026
Personalis is betting that detecting relapse at the molecular level, before it becomes radiographically obvious, can change how cancer is monitored and managed.
Adrian Gottschalk, CEO, Foghorn Therapeutics | Onyx Live | JPM 2026
The machinery that governs gene expression is being targeted to beat cancer.
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.
Johnson & Johnson’s ICOTYDE brings a new oral IL-23 option to plaque psoriasis
On March 17, 2026, the FDA approved Johnson & Johnson’s ICOTYDE (icotrokinra) for adults and pediatric patients 12 years and older who weigh at least 40 kg with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. ICOTYDE is a once-daily oral IL-23 receptor antagonist, and Johnson
FDA approves Alfasigma’s Lynavoy for primary biliary cholangitis
On March 17, 2026, the US FDA approved Lynavoy (linerixibat) for cholestatic pruritus associated with primary biliary cholangitis. The approval came days after GSK and Alfasigma announced a March 9 licensing agreement under which Alfasigma acquired exclusive worldwide rights to develop, manufacture, and commercialize linerixibat. Under the agreement, GSK receives
FDA greenlights Ascendis’ once-weekly YUVIWEL to boost growth in children with achondroplasia
On February 27, 2026, the FDA approved Ascendis Pharma’s YUVIWEL (navepegritide) (ASND, Nasdaq, Close: $233.50 - as of Feb. 27, 2026) to increase linear growth in pediatric patients 2 years of age and older with achondroplasia with open epiphyses. Navepegritide is a once-weekly subcutaneous C-type natriuretic peptide prodrug.
Immedica Pharma’s Loargys adds an enzyme-replacement entrant for ultra-rare ARG1-D–related hyperargininemia
On February 23, 2026, the FDA approved Loargys (pegzilarginase-nbln) from Immedica Pharma for hyperargininemia in adults and pediatric patients 2 years and older with Arginase 1 Deficiency, in conjunction with dietary protein restriction. ARG1-D affects an estimated 250 people in the U.S.A. Immedica Pharma’s CEO, Anders Edvell,
FDA approves Vanda’s Bysanti for schizophrenia and bipolar I manic or mixed episodes
On February 20, 2026, the FDA approved Bysanti (milsaperidone) from Vanda Pharmaceuticals (VNDA, Nasdaq) for schizophrenia and for manic or mixed episodes associated with bipolar I disorder in adults. Vanda describes Bysanti as a new chemical entity atypical antipsychotic that is bioequivalent to iloperidone across the therapeutic dosing spectrum, enabling
Acrotech Biopharma brings a new topical PDE4 option - Adquey - into a crowded eczema market.
On February 12, 2026, the FDA approved Adquey (difamilast 1%) ointment from Acrotech Biopharma for the topical treatment of mild to moderate atopic dermatitis in adults and pediatric patients aged 2 years and older. The commercial question centers on where difamilast can earn durable share against entrenched topicals. Mechanistically, difamilast
FDA approvals - January 2026
Copper replacement formalizes care for a fatal pediatric metabolic disorder.
FDA approvals - December 2025
The winter batch of FDA approvals featured therapies that compress intervention into fewer doses, fewer visits, and fewer points of failure.
FDA Approvals - November 2025
Mitochondrial disease and mutant leukemias signal where specialty pharma is placing its biggest bets.
FDA approvals - September 2025
September’s FDA approvals signaled shifting rules in biopharma - faster launches, smarter formulations, and bold plays from rising innovators and the familiar giants.
Chris Hall, CEO, Personalis | Onyx Live | JPM 2026
Personalis is betting that detecting relapse at the molecular level, before it becomes radiographically obvious, can change how cancer is monitored and managed.
Adrian Gottschalk, CEO, Foghorn Therapeutics | Onyx Live | JPM 2026
The machinery that governs gene expression is being targeted to beat cancer.
Nara Daubeney and Piers Daubeney, CEO and Co-Founder, Phaim | Onyx Live | JPM 2026
Millions of T1DM patients worldwide are on lifelong insulin and constant monitoring. But what if we could switch off the immune attack causing the disease?
Daniel Green, CEO, eSpraye | JPM 2026
If the disease is in the lungs, why deliver the drugs everywhere else?
Fabian Gerlinghaus, CEO, Cellares | Onyx Live | JPM 2026
The platform built to cut CAR-T manufacturing costs by ~50% is about to power its first patient dosing.
Stefan Scherer, CEO, 3T Biosciences | JPM 2026
Many biotechs are trying to perfect T cell targeting - but how many have the backing of Sean Parker and Thiel Capital?
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.”
“Efficacy with safety”: the north star behind Outpace’s next-gen engineered cell therapies
Outpace Bio is using AI-powered protein design to build “software and hardware” into engineered cells aimed at durable solid-tumor responses. For CEO Marc Lajoie, “efficacy is still the fundamental problem that needs to be solved - efficacy and safety.”
From diagnostics to drug development: Scipher Medicine’s three-track strategy for high-impact immunology
As Scipher expands from predictive diagnostics into drug development, CEO Reginald Seeto stresses that technology must drive real clinical decisions: ‘You’ve got to bring technology to the point of greatest impact - otherwise even great innovations never get progressed.’
Why Novellia thinks the best biopharma data strategy starts with patients, not pipelines
“Everything that’s good for patients delivers extraordinary value for biopharma - that overlap is the entire company,” says Shashi Shankar, CEO. From symptom tracking to AI-driven normalization, Novellia builds patient-first data infrastructure that scales into biopharma-grade intelligence.
Mark Lappe’s lean biotech model: smaller teams, bigger wins
Inhibrx has built its drug discovery engine around tight, focused teams. The philosophy is simple: “We’re best when we’re smaller. When teams get too big, they stop innovating,” shaping how programs are advanced or spun out.
The lab-data marketplace powering precision medicine’s next wave
As pharma’s demand for real-time lab intelligence accelerates, Prognos Health is leaning in - and after six or seven years of building, the company now sees “a real path to delivering 20 billion health insights by 2050”, says CEO Sundeep Bhan.
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