Original reporting and analysis on the stories shaping biotech.
The FDA is about to let a panel of peptide-selling doctors and pharmacists vote on whether their own products should be legal. Critics say the July advisory committee meeting is a case study in regulatory capture, with billions in gray-market sales hanging in the balance.
Roche's divarasib just outperformed both approved KRAS G12C inhibitors in a head-to-head Phase 3 trial, hitting superiority on both progression-free survival and overall survival. Wall Street says it's a solid win, but the real billions hinge on what comes next.
Sensorion just reported the first human data from its gene therapy trial in deaf toddlers, and children who previously heard nothing are starting to respond to sound. The results are early, but they could reshape how we treat one of the most common genetic causes of childhood deafness.
MacroGenics just sold its entire manufacturing operation to Bora Pharmaceuticals for $122.5 million, bucking the industry's vertical integration trend. It's a bold bet that a clinical-stage biotech is better off renting a factory than owning one.
United Therapeutics dropped $140 million on a startup that wants to regrow your thymus, the immune organ most people forgot they had. It sounds wild until you realize it might be the missing piece for the company's even wilder plan to manufacture unlimited transplant organs.
Forty private biotech companies raised $100M+ in the first half of 2026, and the largest biotech IPO ever just closed at $625M. But the money is piling into a handful of winners while early-stage companies face their worst funding year in a decade. Welcome to biotech's K-shaped boom.
Ipsen dropped $2.5 billion on two biotech acquisitions in five days, including a Swiss startup targeting a virus that threatens kidney transplants. The science behind the deal is as compelling as the price tag.
Sixth Street and KKR just injected $1 billion of preferred equity into BridgeBio Pharma, one of the largest such deals ever for a public biotech. The unusual structure reveals a new financing playbook for late-stage drug companies caught between clinical success and commercial scale.
Merck killed its Phase 2 trial of MK-1167 after the Alzheimer's drug simply didn't work well enough. With a 99.6% failure rate in the field and only one remaining candidate in their pipeline, Merck's neuroscience ambitions are running out of runway.
Takeda is paying Insilico Medicine up to $600 million to let an AI platform design its next wave of drug candidates. It's the latest mega-deal in a pharma-wide arms race for generative AI, and Insilico's growing roster of blue-chip partners is starting to look like a who's-who of big pharma.
The FDA just approved Orca Bio's Tregzi, the first regulatory T cell therapy designed to make bone marrow transplants dramatically safer. In its pivotal trial, 78% of patients survived without serious GVHD at one year, versus just 38% with standard transplants. This one's worth understanding.
For nearly 50 years, carbapenems were the most powerful antibiotics in medicine, but they required an IV and a hospital bed. GSK just changed that with the first-ever oral carbapenem, and the implications for millions of UTI patients (and antibiotic resistance) are enormous.
Medicare's new GLP-1 Bridge pilot offers weight-loss drugs like Wegovy and Zepbound to seniors for just $50 a month, blowing past decades of coverage bans. It's a multibillion-dollar bet that treating obesity now will save money later, and Wall Street is already picking winners.
Celea Therapeutics just raised $180M for a single lung disease drug, dwarfing typical respiratory rounds by 4x. In a market obsessed with obesity and cancer, the investor list (RA Capital, Bayer's venture arm, a sovereign wealth fund) suggests IPF's massive treatment gap might be biotech's most overlooked opportunity.
The FDA just launched two clinical trials that stream data to regulators live, not months after the fact. If the experiment works, it could reshape how fast drugs get developed and approved in the U.S.
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.
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