Original reporting and analysis on the stories shaping biotech.
Corcept Therapeutics just got FDA approval for the first drug that blocks cortisol from shielding tumors against chemotherapy. The approval came nearly four months early, and it could reshape treatment for the thousands of ovarian cancer patients who've run out of options.
Europe just approved the world's first combined flu-COVID vaccine, and it's not even close to what you'd expect. Moderna's single-shot mRNA combo could upend a $10 billion market, but the real battle is just getting started.
ARPA-H just dropped $160 million to turn one-of-a-kind gene therapies into repeatable platforms. Seven teams, seven disease areas, and a bold bet that personalized genetic cures can be mass-customized like everything else in modern life.
GSK's Hansoh-partnered ADC just delivered the first-ever Phase 3 survival win for a B7-H3-targeted drug in any cancer, and it happened in one of oncology's deadliest diseases. The numbers aren't out yet, but the signal is unmistakable.
The Trump administration is threatening 100% tariffs on imported brand-name drugs while simultaneously striking pricing deals with 16 pharma giants covering 86% of the branded market. The discounts look massive on paper, but the fine print tells a more complicated story.
Europe's drug safety watchdog flagged a small brain tumor risk linked to widely used progestin contraceptives containing desogestrel and etonogestrel. The finding could affect prescribing for millions of women and force label changes on products like Nexplanon.
The FDA rejected Elevar and Hengrui's liver cancer combo for the third time, and it has nothing to do with whether the drug works. The culprit is a manufacturing facility in China that keeps failing inspection, threatening a billion-dollar deal while competitors cement their grip on the market.
Germany's parliament just passed sweeping drug pricing reforms that squeeze pharma margins from every angle. The ripple effects could reshape how medicines are priced across all of Europe.
Bayer just pulled €3 billion from Apollo without giving up control of its blockbuster IUD franchise. It's a clever financial move, but the real story is why the German pharma giant needed the cash so badly in the first place.
The FDA approved a wearable on-body injector version of Sanofi's myeloma drug Sarclisa, making it the first cancer therapy in the U.S. delivered this way. It won't dethrone J&J's Darzalex overnight, but it just erased one of the biggest reasons doctors defaulted to the competition.
MeiraGTx scooped up a gene therapy J&J abandoned, then locked in $400 million in non-dilutive funding from Oberland Capital to bring it to market. The deal structure, the pipeline, and the risks tell a fascinating story about how gene therapies actually get financed.
Roche terminated both its Huntington's disease ASO programs in a single announcement, including its decade-long flagship partnership with Ionis. The double failure raises hard questions about whether the field's best strategy for tackling the disease actually works in humans.
The Trump administration just slapped a 100% tariff on imported brand-name drugs, the steepest Section 232 rate ever applied to a single product category. But the real story is in the escape hatches: cut your prices, build a factory in America, or pay double at the border.
Valneva pulled the world's only approved chikungunya vaccine from the U.S. after it was found to cause the very disease it was supposed to prevent. With the virus spreading northward and no replacement on American shelves, the withdrawal exposes a gaping hole in tropical disease preparedness.
Fate Therapeutics' off-the-shelf CAR-T therapy showed clean safety and improved symptoms in all four systemic sclerosis patients treated so far. It's the latest sign that cancer's most powerful weapon might have a second career in autoimmune disease.
Moderna just launched the world's first Phase 3 trial of an mRNA bird flu vaccine, right as H5N1 creeps closer to becoming a human problem. But the U.S. government already pulled $766 million in funding, so who's actually paying for this pandemic insurance policy?
Moderna just scored EU approval for the world's first combined flu-COVID vaccine, beating every competitor to the punch. The single-shot approach outperformed getting both vaccines separately, and it could reshape how hundreds of millions of people vaccinate each fall.
BMS's precision combo of Krazati plus cetuximab shrank colorectal tumors at nearly three times the rate of chemotherapy, yet patients didn't live a single day longer. The confirmatory trial failure threatens an accelerated approval and raises hard questions about targeted therapy's limits in GI cancers.
Samsung Bioepis just posted the first-ever Phase 3 data for a Keytruda copycat, and it matched the $32 billion original on every measure. With at least ten companies racing to build biosimilar versions of the world's best-selling drug, the countdown to cheaper cancer immunotherapy has officially begun.
China just added semaglutide to its essential medicines list, making it the second GLP-1 drug prioritized for the world's largest diabetes population. With 233 million patients, expiring patents, and a wave of domestic competitors, the move could reshape the global GLP-1 market in ways Novo Nordisk and Eli Lilly didn't plan for.
Four adult Duchenne patients showed less fat in their muscles after six months on Satellos' experimental drug, reversing a trajectory that was supposed to be a one-way street. The data are tiny but the implications are massive.
Trump's new tax bill restores immediate R&D expensing for biotech, but Medicaid cuts, tariffs, and MFN pricing could quietly erode the industry's revenue outlook. The fine print tells a very different story than the headline.
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