Original reporting and analysis on the stories shaping biotech.
Jazz Pharma's Zepzelca just failed the confirmatory trial the FDA demanded, putting its accelerated approval on the chopping block. But a separate trial win in a different setting might save the drug's entire commercial future.
A hacking group claims it stole over a terabyte of Novo Nordisk's most sensitive data, including AI models, drug formulas, and clinical trial records, then demanded $25 million. The company refused to pay. Now the data is hitting the dark web.
The Trump administration threatened 100% tariffs on imported branded drugs. Pharma's response? Over $300 billion in pledged U.S. manufacturing investments, a wave of direct-to-consumer sales channels, and the biggest reshoring scramble the industry has ever seen.
Sanofi killed its Phase 3 MOBILIZE trial of riliprubart in refractory CIDP after an interim analysis showed the drug was unlikely to work. The fallout raises hard questions about complement inhibitors in nerve disease, and the patients left without options.
Novartis just signed its second collaboration with Orionis Biosciences, a $1.4 billion bet on molecular glue degraders that could crack open the 80% of disease targets traditional drugs can't reach. It's the latest in a protein degradation spending spree that now totals over $10 billion in potential milestones.
STAT News drops a major investigation into billionaire Patrick Soon-Shiong's decade of bold pancreatic cancer claims. The data behind his "breakthrough" therapies tell a very different story than his public promises.
Grail's Galleri blood test found cancer four times more often than standard screening in a massive NHS trial. There's just one problem: it completely failed to prove that catching cancer earlier actually reduces late-stage disease.
An FDA advisory panel just voted 9–0 to back Moderna's mRNA flu vaccine, the first of its kind. After 80 years of egg-based manufacturing, the seasonal flu shot is about to get a radical upgrade.
Moderna and Merck's personalized mRNA cancer vaccine held strong over five years, cutting melanoma recurrence risk in half when added to Keytruda. With a phase 3 trial fully enrolled and a potential FDA filing on the horizon, this could be the most important cancer vaccine story of the decade.
The FDA just approved the first-ever PROTAC drug, a class of medicine that destroys disease-causing proteins instead of blocking them. After 25 years of development, vepdegestrant's green light could reshape how the entire industry thinks about drug design.
The FDA just approved the first checkpoint inhibitor plus HIF-2α inhibitor combo for post-surgery kidney cancer. Merck's KEYTRUDA + WELIREG beat KEYTRUDA alone in a landmark trial, and Wall Street sees a potential $6 billion peak opportunity.
A brand-new startup just raised $180 million to develop an oral IBD drug that targets PDE4B with sniper-like precision. With 5 million IBD patients worldwide stuck choosing between drugs that don't work and drugs that make them miserable, cAMPfield Therapeutics is betting big that selectivity is the key to cracking one of gastroenterology's toughest problems.
The FDA just gave Merck's CAPVAXIVE vaccine a pediatric expansion for high-risk kids aged 2-17, cracking open a door that Pfizer's Prevnar franchise had locked shut. In the multibillion-dollar pneumococcal vaccine war, Merck's adult-optimized shot now has a foothold across the age spectrum.
Seven years into a clinical trial, more than half of metastatic lung cancer patients on Pfizer's lorlatinib still haven't progressed. Oncologists are starting to whisper the word "cure," and the data might actually justify it.
A single IV infusion of Verve's gene-editing therapy slashed LDL cholesterol by 62% and kept it there for over a year. If the safety data hold up, the era of lifelong cholesterol pills might have an expiration date.
For decades, scientists knew exactly what caused narcolepsy but couldn't build a drug to fix it. Now, two companies have cracked one of the hardest problems in neuroscience, and the results are rewriting what's possible in CNS drug development.
GSK is spending roughly $11 billion to acquire Nuvalent and its two FDA-reviewed lung cancer drugs, marking one of the biggest oncology deals of 2026. Wall Street likes the strategy but questions whether the price leaves any room for error.
A top venture capitalist just went public against Washington's push to restrict biotech investment in China. With $136 billion in cross-border licensing deals at stake, the fight over where America's next drugs come from is getting very personal.
F2G and Shionogi's olorofim just passed Phase 3, becoming the first new class of antifungal in 20 years to reach the regulatory filing stage. For a field where ICU mortality can top 90% and doctors still rely on a drug nicknamed "amphoterrible," this one matters.
The team that built MyoKardia into a $13 billion acquisition just pulled off one of 2026's biggest biotech IPOs. Kardigan raised $400 million at the top of its range, and the story behind the deal says as much about the market as it does about the company.
The FDA just cleared Beam Therapeutics to test a gene therapy that fixes a single DNA "typo" causing PKU, a disease that forces patients into a lifetime of brutal dietary restriction. Base editing has never been tried in metabolic disease before, and this trial could reshape the field.
Jazz Pharmaceuticals just committed up to $4 billion for drugs that don't exist yet, partnering with AbCellera to crack one of oncology's hardest puzzles: making T-cell engagers work in solid tumors. The deal structure is smarter than the headline suggests.
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