Original reporting and analysis on the stories shaping biotech.
The FDA rejected Replimune's melanoma gene therapy RP1 for the second time, citing the same trial design flaws it flagged five years ago. The decision sends a chilling message to every company betting on oncolytic virus therapies with single-arm studies.
The FDA just approved Eli Lilly's Foundayo, an oral GLP-1 pill for obesity that you can pop any time of day without fasting or needles. With two-thirds of injectable patients quitting within a year, this little tablet could blow the market wide open.
Neurocrine Biosciences is spending $2.9 billion to acquire the only approved drug for a rare hunger disorder most people have never heard of. The deal says a lot about where biotech's biggest bets are heading.
Biotech IPOs raised $1.7 billion in Q1 2026, the biggest quarter since 2021, with median deal sizes more than doubling. But the real story isn't just the money coming back; it's about which companies are getting funded and what Eli Lilly's aggressive shopping spree tells us about what's next.
The FDA rejected Replimune's melanoma drug RP1 for the second time, despite strong response rates and breakthrough therapy designation. The decision sends a clear signal: single-arm oncology trials may no longer cut it for approval.
A veteran cell therapy CEO just jumped ship to lead a radioactive cancer therapy company. Frédéric Desdouits' move from TreeFrog Therapeutics to Orano Med is the latest sign that targeted alpha therapy is pulling the biotech industry's best talent into its orbit.
A 21-mile-wide waterway between Iran and Oman is nearly shut down, and it's quietly threatening the global drug supply. No shortages yet, but the clock on pharma's inventory buffers is ticking.
Almost every RNA drug on the market goes to the liver. Vivatides Therapeutics just raised $54 million to deliver RNA everywhere else, tackling one of biotech's hardest unsolved problems.
Biotech IPOs raised a record $1.7 billion in Q1 2026, but only a select few made it through the door. The public market has become an exclusive club where late-stage data and billion-dollar backing are the price of admission.
Eli Lilly and Biogen dropped nearly $14 billion in acquisitions on the same day, sending the biotech index soaring 7%. It might be just the beginning of a record-breaking M&A year.
Eli Lilly just got FDA approval for Foundayo, the first small-molecule obesity pill that you can take anytime, anywhere, no needles required. With $1.7 billion in projected first-year sales and a price that undercuts injectables by 85%, the GLP-1 wars just went oral.
A small biotech developing a promising liver disease treatment was killed not by bad science or a failed trial, but by a single FDA meeting cancellation. Kezar Life Sciences' collapse reveals how regulatory delays are becoming an existential threat to the companies driving biomedical innovation.
AI companies are stealing investor dollars while Chinese drugmakers do the same science at a fraction of the cost. STAT News talked to two dozen biotech VCs and LPs, and the consensus is clear: the old playbook is breaking.
A woman who needed daily blood transfusions to survive had three autoimmune diseases wiped out by a single cancer therapy. The case is the first of its kind, and it's accelerating a billion-dollar race to bring CAR-T beyond oncology.
The nation's top health official demands more research on vaccines but personally injects peptides that have never passed a human clinical trial. A STAT News analysis highlights the contradiction at the heart of HHS, and it could reshape how the FDA regulates everything.
Avalyn Pharma just filed for a Nasdaq IPO to fund inhaled lung disease therapies that deliver 35x more drug to the lungs with a fraction of the side effects. The concept is deceptively simple: skip the pill, breathe in the cure.
About 6,000 women enter menopause daily in the U.S., and the market opportunity tops $120 billion. So why does the pharmaceutical industry keep stumbling on drugs for it? The answer involves ghost studies, broken trial designs, and a system that still treats half the population's health as a niche.
A Shanghai biotech just raised $110 million to chase what nobody has achieved: a CAR-T therapy that actually works against solid tumors. Oricell Therapeutics is betting it can crack liver cancer and IPO on the other side.
Analysts are calling lipoprotein(a) inhibitors biotech's next blockbuster category, with comparisons to the GLP-1 obesity gold rush. With 65 million eligible U.S. patients and zero approved treatments, the first definitive trial results are expected this summer.
Researchers found that toxic sugars made by gut bacteria can trigger ALS and frontotemporal dementia by sparking immune attacks on the brain. The discovery could explain why some people with high-risk genes never get sick, and clinical trials targeting this gut-brain pathway could begin within a year.
Life Biosciences just raised $80 million to test whether a gene therapy can literally rejuvenate aging cells inside the human eye. It's the first epigenetic reprogramming therapy to reach human trials, and the implications go way beyond glaucoma.
Novo Nordisk just bet up to $2.1 billion on a 40-person MIT spinout that built a miniature gut on a chip. The deal could reshape how obesity drugs reach patients, and it signals that the next frontier in the weight-loss wars isn't a new molecule; it's a better pill.
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