Original reporting and analysis on the stories shaping biotech.
The FDA just approved the first drug that fights the autoimmune attack behind childhood type 1 diabetes, not just its symptoms. It's not a cure, but it cracks open an entirely new treatment paradigm for 18,000 kids diagnosed every year.
Regeneron's cemdisiran just earned FDA Priority Review for myasthenia gravis, promising patients a single subcutaneous shot every three months instead of IV infusions. The RNA-based drug silences complement protein production at the source, and its Phase 3 data suggest less immune suppression might actually work better.
Exelixis' next-generation drug zanzalintinib missed a key survival endpoint in colorectal cancer, sending shares down 10-12%. With Cabometyx still driving 90% of revenue, the pressure to prove the successor can carry the franchise just got a lot more intense.
HHS says biotech companies have been submitting mountains of manufacturing data that FDA never actually required for Phase 1 trials. Operation TrialBlazer aims to cut 6–12 months off first-in-human timelines, and the implications for cash-strapped startups are massive.
Merck's $10.8 billion acquisition of Prometheus Biosciences just delivered: tulisokibart became the first anti-TL1A antibody to hit its primary endpoint in a Phase 3 ulcerative colitis trial. With analysts projecting $5.2 billion in peak sales and a 2027 launch, this is Merck's biggest post-Keytruda moment yet.
The FDA is now watching clinical trial data stream in live from AstraZeneca and Amgen studies, ditching the old batch-submission model entirely. It's the biggest change to how regulators oversee drug development in decades, and a broader pilot launches this summer.
The FDA refused to even review Moderna's mRNA flu vaccine application. Then, according to Politico, the President called the FDA commissioner to the White House. A week later, the agency reversed course. What that means for the future of drug regulation is worth paying attention to.
Definium Therapeutics just dropped Phase 3 data for its LSD-derived depression pill that blows past every benchmark in psychiatry. One dose, no therapy required, and effects lasting three months. The psychedelic drug race just got a new frontrunner.
Novo Nordisk's next-gen obesity drug CagriSema was built to match Eli Lilly's tirzepatide. It failed a head-to-head Phase 3 trial, sending Novo's stock plunging and wiping out hundreds of billions in market value. The obesity drug throne just got a lot harder to reclaim.
A brand-new French biotech just raised $165 million without discovering a single molecule. Bionyra Pharma launched with three licensed inflammation drugs already in or near the clinic, riding a wave of in-licensing deals that's reshaping how biotech companies get built.
Eli Lilly just paid $10 million for a Swedish Alzheimer's drug that doesn't exist as a pill yet, with milestone payments that could top $1 billion. The deal reveals Lilly's audacious plan to own every layer of Alzheimer's treatment, from cleanup to prevention.
Biopharma M&A has hit $106 billion across 201 deals in 2026, and analysts say the industry could blow past its all-time record. From obesity bidding wars to billion-dollar cancer platform grabs, here's why Big Pharma can't stop buying.
Pfizer and China's Innovent Biologics hammered out one of the largest cross-border biotech deals in history in just five months. The $10.5 billion oncology collaboration spanning 12 cancer programs reveals how urgently Pfizer is racing to rebuild its pipeline after the COVID cliff.
SK Biopharmaceuticals just signed one of the largest AI drug discovery deals ever with Insilico Medicine, worth up to $2.5 billion. The catch? Only $18 million is guaranteed upfront, and the rest hinges on cracking one of medicine's hardest puzzles: neuroimmune disease.
The FDA is getting a live data feed from two oncology trials run by AstraZeneca and Amgen, ditching the decades-old model of waiting months between data checkpoints. If it works, drug development timelines could shrink by years.
AbbVie is paying $10.9 billion in cash for Apogee Therapeutics, a company that was founded just four years ago. The prize: an eczema drug that could challenge Dupixent with dramatically less frequent dosing. Wall Street says the price is steep but justified.
The FDA just approved Rextovy as the latest over-the-counter naloxone nasal spray, and it could show up next to the cold medicine at your local pharmacy. With nearly 70,000 Americans still dying from overdoses annually, the race to get this antidote everywhere just got a new competitor.
Sarepta's Elevidys, the most closely watched gene therapy in rare disease, just failed its Phase III confirmatory trial, triggered a black box warning, and forced 500 layoffs. The fallout could reshape how the FDA handles gene therapy approvals for years to come.
Astellas is betting $1.7 billion on a cancer drug that stays completely dormant until it reaches the tumor. VIR-5500's masked T-cell engager technology posted an 82% response rate with almost no serious side effects, and it could reshape how we treat prostate cancer.
Novo Nordisk licensed a French biotech's molecular delivery platform in a deal worth up to $327 million, betting that getting drugs past the blood-brain barrier is the next great competitive advantage. The deal is part of a massive pharma arms race over targeted tissue delivery that's reshaping biotech dealmaking.
GSK just dropped roughly $1 billion to combine two RNA-based drugs into what could be the first functional cure for chronic hepatitis B. With 250 million people infected and current therapies curing fewer than 1%, the stakes couldn't be higher.
Pfizer is launching 10 Phase 3 obesity trials in 2026, anchored by a $10 billion acquisition and a once-monthly GLP-1 injection. With $17 billion in revenue about to vanish from patent expiries, this is the company's biggest strategic gamble in years.
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