Original reporting and analysis on the stories shaping biotech.
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.
The FDA just picked seven companies, including Eli Lilly and Regeneron, for a first-of-its-kind pilot that reviews drug factories while they're still being built. It could shave over a year off the path to market.
A stealth biotech you've never heard of just signed a $1.6 billion deal for a preclinical drug designed by AI. Boulevard Bio's bet on trispecific T-cell engagers for autoimmune disease could be brilliant, reckless, or both.
Vir Biotechnology's "masked" T-cell engager posted eye-popping tumor responses with almost no serious side effects in prostate cancer patients. Astellas liked what it saw enough to write a $1.7 billion check.
Novo Nordisk's next-gen obesity drug CagriSema just lost a decisive head-to-head trial against Eli Lilly's Zepbound, sending shares plunging 15% and reshaping the most valuable drug market in a generation. The fallout is massive, and Novo's path back to the top just got a lot steeper.
Otsuka's centanafadine just posted positive Phase 3b results in adults with both ADHD and anxiety, hitting endpoints on both conditions with a single pill. With an FDA decision due July 24, this triple-reuptake inhibitor could reshape how doctors treat one of psychiatry's most common (and frustrating) combos.
AstraZeneca's next-gen successor to Strensiq crushed its pediatric trials but whiffed on the primary endpoint in adults. The mixed Phase 3 results put the company's multi-billion-dollar rare disease expansion plan on shaky ground.
Novartis pulled the plug on cancer candidate QEQ278 after it failed to shrink tumors in any of the 30 patients who received it. The zero-for-30 result is a stark reminder of oncology's brutal attrition rates, but it also reveals a lot about how Novartis is reshaping its pipeline.
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