Original reporting and analysis on the stories shaping biotech.
Tempus AI just got FDA clearance to turn the most common heart test in medicine into a screening tool for a deadly disease that doctors routinely miss. The twist: hospitals don't need any new equipment.
A cardiac drug startup that didn't exist two years ago just raised $440 million in its Nasdaq debut. Braveheart Bio's blockbuster IPO headlined a billion-dollar week for biotech, and it all rides on a single heart drug.
For patients with a rare liver disorder, life means waking up every few hours to eat raw cornstarch or risk a medical emergency. Ultragenyx's gene therapy DTX401 cut that dependence by 61% in trials, and the FDA's decision could open the floodgates for a whole new class of metabolic gene therapies.
Repligen is spending $1.5 billion to acquire BioLife Solutions, the company whose products keep cell therapies alive from factory to patient. The deal says everything about where bioprocessing M&A is headed next.
The FDA commissioner allegedly tried to personally reject KalVista's rare disease drug, an almost unheard-of level of political intervention in drug approvals. The drug got approved anyway, but the episode reveals a troubling pattern at Makary's FDA.
Eli Lilly is spending up to $3.8 billion to acquire AtaiBeckley and its psychedelic-derived depression drugs. It's the biggest bet Big Pharma has ever placed on psychedelic medicine, and it might just redraw the map for mental health therapeutics.
Moderna and Merck just delivered the first-ever positive Phase 3 result for an mRNA cancer vaccine, sending Moderna's market cap soaring by $45 billion in a single day. The personalized melanoma vaccine could reshape oncology and rewrite Moderna's post-COVID narrative.
Australia just confirmed H5N1 bird flu in a local mammal for the first time: a long-nosed fur seal found on a South Australian beach. It's a quiet milestone with loud implications for pandemic preparedness, and it signals the virus is finding new footholds in the Southern Hemisphere.
Taiho and Cullinan just dropped positive Phase 3 lung cancer data that puts them on a collision course with J&J's Rybrevant franchise. The full numbers aren't out yet, but Wall Street is already raising its eyebrows.
PTC Therapeutics scooped up a near-approval gene therapy from a bankruptcy auction for $211 million, with most of the price tag tied to FDA approval. It's a bold bet on Fabry disease that could reshape the company's future.
Eli Lilly dropped $750 million on a manufacturing deal for a pen. Not a drug, not a molecule: a pen. But when GLP-1 demand is this insatiable, the company that can actually deliver wins.
A new HHS document reveals fresh details about RFK Jr.'s plans to overhaul federal vaccine policy, from splitting up the MMR shot to creating entirely new recommendation categories. For vaccine makers already reeling from 18 months of policy shifts, the 30-day comment period feels less like a question and more like a foregone conclusion.
A Polish drugmaker you've probably never heard of just proved its semaglutide copycat matches Ozempic in an early clinical study. The GLP-1 pricing war is quietly starting, and the battlefield is bigger than you think.
Capricor's cell therapy for Duchenne muscular dystrophy faces a likely FDA rejection after advisors voted 9-to-3 against it, and activist investor Kaos Capital is simultaneously demanding a full boardroom overhaul. It's a two-front war that could determine the company's survival.
Supernus and Indivior are merging to create a $2.2 billion-revenue CNS giant spanning addiction, ADHD, depression, and Parkinson's. Supernus shareholders get a 38% premium, Indivior shareholders get a $1 billion cash dividend, and Wall Street is already split on whether the math works.
Sarepta's Duchenne gene therapy Elevidys just earned the FDA's most severe warning after two boys died from liver failure. Now the company is slashing 36% of its workforce and fighting for survival. The gene therapy revolution's darkest chapter is still being written.
Sentynl Therapeutics just struck a deal worth up to $475 million for an oral lung disease drug that doesn't exist yet as an approved treatment. The option-to-license structure reveals how specialty pharma is quietly reshaping rare disease dealmaking.
Werewolf Therapeutics just agreed to a $150 million reverse merger with Ambros Therapeutics, ditching cancer immunotherapy for a non-opioid painkiller. The deal was oversubscribed, the pivot is dramatic, and it's part of a much bigger trend reshaping how biotechs go public.
Sandoz just dropped up to $322 million on a licensing deal with Shanghai's Henlius Biotech for as many as ten biosimilar products. It's the latest power move in the company's post-Novartis strategy to dominate the global biosimilar market, and it says a lot about where Western pharma is finding its next blockbusters.
For 20 years, Big Pharma tried and failed to build a drug targeting 4-1BB, immunology's most tantalizing "turbo button." Now a Nanjing biotech just got its filing accepted in China, and it could become the first approved 4-1BB therapy in the world.
Resilience raised over $2 billion to build America's biotech manufacturing future. Now it's shutting down six sites through a strategic bankruptcy play, and the ripple effects could hit supply chains across the industry.
The FDA just cleared a blood test that can screen for Alzheimer's in adults as young as 40, potentially replacing expensive PET scans as the diagnostic front door. With two amyloid-targeting drugs now on the market and patients stuck in a diagnostic traffic jam, this could change everything about who gets treated and when.
Join thousands of biotech professionals who start their day with our free, daily briefing.