Original reporting and analysis on the stories shaping biotech.
The Trump administration just made psychedelic therapies a federal healthcare priority, committing $50 million in funding and fast-track review vouchers for psilocybin and related compounds. It's the biggest shift in U.S. psychedelic policy in half a century, and the implications for patients, investors, and the future of psychiatry are enormous.
The FDA approved Lilly's oral obesity pill Foundayo in record time, then handed the company a 15-year monitoring homework assignment. What the agency's unprecedented post-marketing demands mean for the future of diet pills, and the entire oral GLP-1 class.
Merck poured $1 billion into a Durham vaccine factory to meet booming Gardasil demand. Now it's shutting the plant down and cutting 154 jobs as HPV vaccine sales crater 39%, with China shipments frozen indefinitely.
STAT News called Revolution Medicines' pancreatic cancer drug 'one of the most exciting cancer medicines in years.' With Phase 3 data showing roughly doubled survival and a plenary slot at ASCO 2026, this could be the biggest moment in pancreatic cancer treatment in decades.
The FDA's new acting commissioner is a corporate lawyer whose entire agency experience is in food regulation. After Marty Makary's chaotic ouster, biotech is relieved to get a "no-drama caretaker," but the real question is what comes next.
The Trump administration just slapped a 100% tariff on every branded drug not made in America, forcing pharma companies into an impossible choice: slash prices, build U.S. factories, or watch their margins evaporate. The biggest shake-up in pharma trade policy is already reshaping the industry.
AC Immune's co-founder just stepped down after 23 years at the helm, right as the company faces multiple pivotal data readouts and billions in partnership milestones. The Alzheimer's field is entering its most competitive era, and the timing couldn't be more interesting.
The FDA just shut down one of the only late-stage trials for a devastating hunger disorder. Now Aardvark Therapeutics is cracking open its Phase 3 data early in a high-stakes gamble to save the program.
Create Medicines just raised $122M to build CAR-T cells directly inside patients' bodies, no blood collection or factory required. With 50-plus patients already dosed, the company claims the largest clinical dataset in in vivo CAR-T, and some of biotech's sharpest investors are doubling down.
Regenxbio's DMD gene therapy just posted jaw-dropping pivotal trial results, tripling the protein output of Sarepta's Elevidys with a fraction of the liver toxicity. In a gene therapy sector desperate for good news, this might be the biggest win in years.
Servier, a privately held French pharma company, just paid $2.5 billion for Day One Biopharmaceuticals and its pediatric brain tumor drug. It's the latest in a wave of European mid-caps buying U.S. biotechs, and it says something important about where pharma M&A is headed.
A boy treated with AAV gene therapy for a fatal childhood disease developed a brain tumor four years later, and molecular evidence points directly to the viral vector. It's the first case of its kind, and it's forcing the entire gene therapy field to rethink what "safe" really means.
ICON just opened a 131-bed clinical research campus in San Antonio with satellite clinics in Houston and Kansas. It's a calculated bet that the future of drug testing belongs to the cities nobody expected.
Lexicon Pharmaceuticals nearly doubled its cash reserves, posted a 96% smaller loss, and now its CEO is signaling an aggressive expansion push. With four pipeline catalysts packed into the next 12 months, the tiny specialty pharma company is betting big.
The FDA just approved the first BCL-2 inhibitor specifically for mantle cell lymphoma, giving patients who've run out of options a new oral treatment. But it came with an asterisk that could change everything.
Fosun Pharma just paid $60 million for the option to license a daily Alzheimer's pill from South Korea's AriBio, in a deal worth up to $4.7 billion. With Phase 3 data expected this year, the bet could reshape the Alzheimer's market or evaporate entirely.
Takeda just killed its fourth consecutive nausea and vomiting drug candidate, going a perfect 0-for-4 in the space. For a company that built its name on gut medicine, the retreat raises uncomfortable questions about what went wrong.
Two companies got into a bidding war over a single-product pharma company with shrinking revenue and no pipeline. The final price: a 76% premium that says a lot about how the market values small-cap pharma right now.
Biogen's tau-targeting Alzheimer's drug missed its primary endpoint in a Phase 2 trial. Instead of pulling the plug, the company is charging ahead to Phase 3, pointing to cognitive and biomarker signals that no tau drug has ever produced before. It's either a bold move or a familiar mistake.
U.S. biotech companies are quietly moving their earliest human trials to Europe and Australia as FDA layoffs and regulatory chaos shake confidence in American drug development. The $635 billion U.S. pharma market might not be enough to keep them home.
Valneva is slashing up to 15% of its workforce as the travel vaccine market fails to deliver on post-pandemic hype. But buried beneath the cuts is a Lyme disease vaccine that could change everything, if the company survives long enough to find out.
Boehringer Ingelheim just dropped up to €407 million on a preclinical antibody from a startup most people have never heard of. The bet: that killing rogue immune cells, not just blocking their signals, is the future of autoimmune medicine.
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