Original reporting and analysis on the stories shaping biotech.
Kalshi just launched 13 prediction market contracts letting traders bet real money on Phase 3 trial results and FDA approvals. It could reshape how investors price pipeline risk, or it could be a magnet for insider trading. The experiment is live.
Jennifer Doudna's team used AI to design gene-editing enzymes that don't exist in nature, and they work in human cells. The implications for CRISPR's future (and its messy patent landscape) could be enormous.
The FDA just hit 25 telehealth companies with warning letters for marketing compounded knockoffs of Ozempic and Mounjaro with bogus claims. It's the third enforcement wave in under a year, with over 100 total letters sent, and the real numbers on patient harm are alarming.
The European Commission accused Sanofi of running a smear campaign against a rival flu vaccine, and it could change how every pharma company in Europe markets its products. Sanofi is already offering to play nice, but the implications go far beyond one company.
Novartis dropped $1.1 billion upfront on a UK biotech whose lead drugs have never been tested in humans. The bet: a completely new class of ADC payload that could rewrite the rules of cancer treatment, or become pharma's most expensive preclinical flameout.
AbbVie is spending $10.9 billion to acquire Apogee Therapeutics, its biggest deal in five years, betting on a single molecule that could reshape the atopic dermatitis and asthma markets. Wall Street is surprisingly on board, but the payoff won't arrive until 2032.
Sobi's gout therapy NASP nailed its clinical trials, but the FDA blocked approval over manufacturing deficiencies. It's the latest example of a striking trend: roughly 74% of FDA rejection letters now cite factory problems, not failed science.
Pfizer just recalled the only FDA-approved drug that can stop syphilis from passing to unborn babies, and there's no real substitute for pregnant patients. With congenital syphilis already at its highest levels in decades, the timing couldn't be worse.
Sun Pharma just got approval to sell generic Ozempic in South Africa, making it only the second country in the world with a cheaper semaglutide alternative. It's a small market, but it could be the first domino in GLP-1 commoditization across emerging economies.
J&J killed its second eye gene therapy program in a year after PARASOL trial data fell flat. The eye was supposed to be gene therapy's easiest target, so why does the field keep striking out?
The FDA just approved the first-ever regulatory T-cell therapy, and it's not even close to a marginal improvement. Orca Bio's Tregzi doubled chronic GVHD-free survival in transplant patients, creating a whole new category of immunotherapy that has 29 other companies watching very carefully.
Sarepta's Duchenne gene therapy Elevidys just got the FDA's most severe safety warning after fatal liver failures, while the company slashes 36% of its workforce and pivots away from gene therapy entirely. It's a brutal week that raises big questions about the future of the entire field.
The European Commission just approved the first oral GLP-1 weight-loss pill, making Novo Nordisk's Wegovy tablet available across the EU. It could unlock treatment for millions of patients who refused to pick up a needle.
Congo just started testing Gilead's oral antiviral obeldesivir as post-exposure prevention during an active Bundibugyo Ebola outbreak that has killed over 700 people. With no approved treatments for this Ebola species, the trial could reshape how the world fights outbreaks.
Insilico Medicine and Bora Pharmaceuticals just announced a potential $2.5 billion AI alliance, but it's not about discovering drugs. It's about completely rethinking how they're manufactured. Welcome to AI's next frontier in pharma.
Biogen's anti-tau Alzheimer's drug missed its primary endpoint but delivered "unprecedented" tau reduction and meaningful cognitive benefits at the lowest dose. Now they're betting on a Phase 3 trial that could reshape the entire field.
A Minnesota diagnostics company bought a shelved Pfizer drug for $10 million in 2021. Five years later, it just got FDA approval for breast cancer, the stock is up 700%, and Big Pharma might come calling.
A three-year-old biotech just filed to go public with plans to take on Dupixent, immunology's $18 billion juggernaut. Attovia Therapeutics has $255 million in venture backing, miniaturized antibodies, and a very long road ahead.
The FDA proposed a new rule that could let drug manufacturers register entire networks of modular production units as a single facility. For cell and gene therapies, it's the regulatory foundation for a future where your cancer treatment gets made down the hall, not across the country.
The FDA just finalized its guidance for psychedelic clinical trials, covering everything from psilocybin study design to how many monitors need to be in the room during a dosing session. It's the clearest regulatory roadmap the field has ever had, and it could put the first approved psychedelic on the market by early 2027.
Q32 Bio's stock surged 60% after its hair-loss drug posted dramatically better results at 36 weeks than it did at 24. The secret weapon isn't raw efficacy; it's a safety and durability profile that could reshape the $4 billion alopecia market.
The FDA went dark on drug rejection letters for three months after a pharma company challenged its transparency policy. Then 14 of them appeared on the public database at once, raising urgent questions about the future of regulatory disclosure in biotech.
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