Original reporting and analysis on the stories shaping biotech.
Whoop is defying an FDA warning letter over its blood pressure feature, calling it wellness while the agency calls it an unapproved medical device. The $10 billion standoff could redraw the line between fitness trackers and regulated medicine for the entire wearables industry.
Amgen paid $3.7 billion for a drug the FDA now says was approved based on manipulated trial data. The company's response: hire Duke to re-crunch the numbers. Whether that's enough to save Tavneos could set a precedent for the entire industry.
The UK just approved the first-ever GLP-1 pill for weight loss, and it works nearly as well as the injection. Novo Nordisk's oral Wegovy could reshape the $150 billion obesity drug market, but the real race is just getting started.
CMS proposed locking in Medicare-negotiated drug prices with limited renegotiation options, turning what pharma hoped was a flexible pricing regime into something much closer to a permanent step-down. For companies sitting on aging blockbusters, the math just changed dramatically.
Roche is paying Nurix Therapeutics $700 million upfront (up to $2.3 billion total) for a drug that physically destroys a cancer-driving protein instead of just blocking it. The deal for BTK degrader bexobrutideg is the loudest signal yet that protein degradation has become big pharma's favorite new weapon.
Eli Lilly's retatrutide slashed sleep apnea severity by 60.6% in a Phase 3 trial, posting numbers that appear to top its own FDA-approved Zepbound. The obesity drug wars just expanded well beyond the bathroom scale.
Roche's obesity drug enicepatide posted 22.5% weight loss in 48 weeks, landing squarely in Zepbound territory and turning Roche from a latecomer into a legitimate contender. The real question: can it compete with what Lilly and Novo are cooking up next?
The FDA just went nuclear on compounded GLP-1 knockoffs, naming Hims & Hers and threatening seizures and injunctions. The multi-billion-dollar gray market for cheap Ozempic alternatives is about to get a lot smaller, and the fallout is hitting stocks, patients, and Big Pharma's bottom line all at once.
A Japanese biotech just threaded lab-grown heart muscle cells through a catheter and into a patient's failing heart for the first time ever. It's either the future of cardiology or the most ambitious long shot in regenerative medicine.
Takeda's psoriasis pill zasocitinib just more than doubled Sotyktu's skin clearance rate in a direct head-to-head trial, validating a $4 billion acquisition bet. The result could reshape the entire oral psoriasis market before the drug even hits pharmacy shelves.
Novo Nordisk's next-gen obesity shot CagriSema just lost a head-to-head trial against Lilly's Zepbound, wiping out billions in market cap and reshaping the GLP-1 landscape. Novo has a plan B, C, and D, but none of them are ready yet.
The FDA just fast-tracked Roche's immunotherapy filing for early-stage colon cancer, and the data behind it might rewrite treatment guidelines. Tecentriq could become the first approved checkpoint inhibitor in adjuvant colon cancer, a space where the competition is virtually nonexistent.
A new startup just raised $130 million to target the migraine pathway that CGRP drugs can't touch. Slate Medicines is betting that PACAP, a completely independent trigger system, could help the millions of patients who don't respond to current therapies.
Novo Nordisk's new CEO Mike Doustdar just laid out his comeback plan in his first major interview, promising aggressive M&A, pipeline depth, and a tighter focus on cardiometabolic disease. Wall Street's response? Prove it.
IDEAYA Biosciences just posted pivotal data in a rare eye cancer that has almost no effective treatments. The combo therapy cut disease progression risk by 58%, and the FDA filing clock is now ticking.
The FDA just launched its largest-ever coordinated crackdown on compounding pharmacies selling cheap versions of Ozempic and Wegovy, explicitly targeting Hims & Hers in the process. A multibillion-dollar grey market is being dismantled, and the fallout is reshaping telehealth, Big Pharma, and patient access to the most popular drugs in America.
Genentech just fired three vice presidents from its legendary gRED research unit, including Vishva Dixit, a 29-year veteran who literally wrote the book on how cells die. The cuts signal something bigger than a reorg: the end of biotech's most storied research culture as we knew it.
Caribou Biosciences just dropped data showing its off-the-shelf CAR-T cells can match custom-made therapies in fighting blood cancers, with zero cases of graft-versus-host disease across 132 patients. If frozen donor cells can truly rival personalized treatment, the economics of cancer therapy are about to get very interesting.
A new biotech just launched with $101 million and a plan to attack thyroid eye disease at its autoimmune root, not downstream like Amgen's $1.9 billion blockbuster Tepezza. If the science holds up, the implications go way beyond eye disease.
AstraZeneca just launched a massive Phase 3 program for its oral GLP-1 obesity pill, elecoglipron, backed by data showing nearly 12% weight loss. Wall Street says the numbers are solid but not best-in-class, so what's AstraZeneca's real play?
Parabilis Medicines just pulled off the largest venture-backed biotech IPO in history at $670 million, one day after signing a deal with Regeneron worth up to $2.3 billion. The real story isn't just the money; it's what this says about who gets funded in biotech right now.
A new study in Cell Host & Microbe reveals that GLP-1 drugs like Ozempic may fight depression by fertilizing a specific gut microbe that produces a natural "chill pill" for your brain. The finding could dramatically expand what these blockbuster drugs are good for.
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