FDA approvals - October 2025
Scarred lungs and hot flashes are two FDA wins for specialty pharma.
Drug Discovery
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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.
Is a world without eyedrops possible?
SpyGlass Pharma is poised to revolutionize glaucoma treatment by implanting an innovative long-term drug delivery system directly inside the eye. Their treatment promises to continuously release eyedrop medication for 3 years after surgery, as opposed to using eye drops manually every day.
GERD affects millions of Americans. This drug is the first major innovation in three decades.
GERD affects 65 million Americans, yet innovation in treatment had stagnated. Phathom Pharmaceuticals' FDA approval of VOQUEZNA® (vonoprazan) is a big moment for patients.
Let there Belite: the prospect of an oral pill for vision loss
If left untreated, Stargardt disease and Geographic Atrophy almost always lead to vision loss and blindness - but a groundbreaking oral treatment in the last stage of clinical trials offers new hope.
How ImmunityBio is transforming cancer - a treatment in just 30 seconds
“I think I'm blessed with truly the best team in all of pharma… we are doing something that's bigger than all of us!”
