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.
Drug Discovery
Lexicon’s next act: betting big on first-in-class cardiometabolic medicine
“We’re really on the precipice of moving the company into that next stage of maturity,” Dr. Mike Exton
FDA Approvals - November 2025
Mitochondrial disease and mutant leukemias signal where specialty pharma is placing its biggest bets.
Affinia closes $40m Series C: CEO Rick Modi explains how low-dose gene therapy capsids could cure cardiomyopathy
“Over the past year, we have made tremendous progress…” Rick Modi says, as Affinia Therapeutics pushes its BAG3-DCM program toward first-in-human testing, aiming to prove that next-generation capsids can restore heart function at dramatically lower doses.
Four years of progression-free survival: Nuvation Bio wins FDA approval for lung cancer
With a median progression-free survival nearing four years in ROS1 lung cancer, Nuvation Bio’s breakthrough therapy signals a turning point for precision oncology - validating Dr. David Hung’s patient-first vision.
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.
From stealth to spotlight: with $70m Series A, ‘total allergic control’ is Excellergy's goal
Backed by $70 million in Series A funding, Excellergy emerges from stealth with a mission to lead a new era in immunology - targeting the full IgE pathway to redefine how allergic diseases are treated.
A Legend in the making: how Ying Huang is scaling CAR-T to global markets
“After just one single infusion, about a third of patients remained in remission for five years. Some physicians even called it a functional cure,” Ying Huang underlines why CARVYKTI is reshaping expectations in oncology.
CAR-T can only treat 3% of cancer patients. Mongoose Bio is building for the other 97%
Neil Warma explains how Mongoose Bio is pioneering TCR-T therapies that may last longer, tackle more cancers, and require less from patients.
This biotech is targeting the 'immortality switch' to fight blood cancers
Harnessing Nobel Prize-winning insights on telomeres, Geron’s CEO Dr. John A. Scarlett is taking on some of hematology’s toughest challenges—and winning FDA backing in the process.
NVIDIA’s Biggest Bet Yet: How Recursion Is Powering a New Era of AI-Driven Drug Discovery
“Almost all of the data that we use comes from our own laboratories - data generation doing real experiments in human biology… The AI side of things will be commoditized eventually, and the winners will be those who have the strongest data moat in life sciences.”
From Grammys to Gene Therapy: Gaurav Shah’s Rocket-Fueled Revolution in Rare Diseases
A Grammy-winning CEO is taking gene therapy to new heights.
From paper to pancreas: how Aspect Biosystems is leading a bioprinting revolution
A recent multi-billion dollar deal with Novo Nordisk in diabetes and obesity, and an injection of significant funding through a $200 million government partnership - Aspect is worth watching as they enter 2025.
Could a single pill crack the code of treating Alzheimer's disease?
By targeting toxic protein clumps in the brain, Dr. Martin Tolar, founder-CEO of Alzheon, aims to outsmart Alzheimer’s decades ahead of symptoms - and reshape global neurology.
enGene injects new hope into the future of bladder cancer care
Ron Cooper, ex-Albireo CEO, is betting on enGene’s novel gene delivery platform to sidestep BCG shortfalls and transform bladder cancer treatment worldwide.