Original reporting and analysis on the stories shaping biotech.
A venture-backed Danish biotech just licensed an Alzheimer's drug platform in a deal worth over $2.2 billion, backed by some of Europe's biggest life sciences VCs. It's one of the boldest startup bets in neurodegeneration history, and it says a lot about where the smart money is headed.
AstraZeneca agreed to pay up to $1.77 billion for two kidney disease molecules that don't even exist yet, and it's actually the third massive deal they've signed with the same Chinese partner. When big pharma starts throwing billion-dollar checks at your organs, it's time to pay attention.
The FDA just cleared Vertex's CRISPR gene therapy for kids as young as two with sickle cell disease, making it the first gene therapy ever approved for toddlers with blood disorders. The science is stunning, but at $2.2 million a pop, almost nobody can get it yet.
The CDC's own study showed COVID vaccines cut hospitalizations by 55%. It was cleared for publication, scheduled for release, and then personally blocked by the acting CDC director. The Washington Post investigation reveals why.
Moderna's mRNA bird flu vaccine just posted 82.7% efficacy in an interim Phase 3 look, making it the first mRNA pandemic flu vaccine to reach late-stage testing. With H5N1 spreading through U.S. dairy herds and 70 human cases already on the books, the timing couldn't be more urgent.
Sobi's gout drug NASP aced its clinical trials, but the FDA rejected it anyway over manufacturing quality concerns. It's the latest example of a growing industry problem: the factory floor, not the clinic, has become the biggest bottleneck to drug approval.
Europe's drug regulator just recommended revoking Amgen's Tavneos over "incorrect and misleading" clinical trial data, one of the rarest regulatory actions in EU history. The move raises uncomfortable questions about how many approved drugs could survive a second look at their pivotal studies.
China just approved the world's first CAR-T therapy for a solid tumor, breaking a barrier that has stumped the field for over a decade. The survival gains are modest, but the implications for the global cell therapy race are anything but.
The FDA office that reviews every cell and gene therapy in America just lost its third senior leader in months. With 2,500+ active applications on file and a wave of approvals on the horizon, the timing couldn't be worse.
Biogen just paid $100 million upfront (with up to $850M on the table) to lock down worldwide rights to an experimental immune disease drug, going deeper into China while everyone else pulls back. The deal reveals just how irresistible the math is in China's booming autoimmune market.
Europe just approved the world's first vaccine combining flu and COVID protection in a single shot. Moderna's mCOMBRIAX beat the best standalone vaccines in clinical trials, and it arrives at a moment when COVID booster uptake among older Europeans has cratered to under 9%.
The FDA selected seven companies for its first-ever PreCheck pilot, a program that lets the agency review drug factories while they're still being built. It could shave over a year off approval timelines and reshape how biotech thinks about manufacturing.
The FDA slashed 3,000 workers last year. Now it's scrambling to hire 2,200 back, but the math still doesn't add up. Here's what it means for drug approvals, biotech timelines, and whether the regulatory engine can survive the whiplash.
Congress just opened a national security investigation into Merck and AbbVie's clinical trials at Chinese military hospitals. No one's alleging crimes yet, but the implications for how pharma picks trial sites could be massive.
The team that built Metsera into a $10 billion Pfizer acquisition target is teaming up with an AI "scientist" startup to do something nobody's tried: use artificial intelligence to systematically create and launch entire biotech companies. It's either the future of drug development or the most expensive science fair project ever.
BioCryst is shutting down all internal drug discovery and closing the Alabama research center where it was born nearly 40 years ago. The move saves $30 million, but it raises a bigger question: can a biotech company survive without actually doing biotech?
Merck KGaA is spending $11.3 billion to buy Bio-Techne, the company that makes the biological ingredients cell therapies can't live without. It's the biggest life sciences tools deal in over a decade, and it's about to reshape how the entire industry gets built.
A biotech you probably haven't heard of just broke Moderna's eight-year IPO record with a $670 million Nasdaq debut. Parabilis Medicines targets "undruggable" cancers, and Wall Street is betting billions that it can deliver.
An FDA advisory panel voted 9–0 to back Moderna's mRNA flu vaccine for adults 50+, potentially making it the first licensed mRNA seasonal flu shot in the U.S. The unanimous endorsement is even more remarkable given that the agency initially refused to review the application earlier this year.
Genentech just scored FDA Priority Review for Enspryng as the first at-home, self-injectable treatment for thyroid eye disease. In a market long dominated by a single $300K IV therapy, the race to give patients a shot they can take in their pajamas is heating up fast.
Vistagen's anxiety drug fasedienol just went 1-for-3 in Phase 3 trials, torching 80% of the stock's value. The company is betting a post-hoc subgroup signal and an FDA meeting can save a program that Wall Street has all but written off.
Praxis Precision Medicine's epilepsy drug just got a three-month FDA delay, and it's far from the only biotech feeling the squeeze. With roughly 3,500 FDA employees cut since 2025, the agency's review machine is straining under its own weight.
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