Original reporting and analysis on the stories shaping biotech.
Insulet just recalled over 174,000 Omnipod 5 insulin pods after a manufacturing defect caused insulin to leak inside the device instead of reaching patients. With 18 serious adverse events and a history of prior recalls, the diabetes device giant faces mounting questions about quality control.
Inovio just cut 22 employees and is down to $58.5 million in cash, with the FDA questioning whether its only real drug qualifies for the fast lane to approval. For the 17,000 Americans living with a rare throat tumor disease that has zero approved treatments, the next seven months are everything.
Biogen's salanersen showed striking early results in SMA kids who didn't get enough benefit from gene therapy, and it only needs one shot per year. The Phase 3 gauntlet starts now.
China just approved the world's first commercial brain-computer interface implant, beating Neuralink to full regulatory clearance. The device lets paralyzed patients control a robotic glove with their thoughts, and it's heading to hospitals now.
The U.S. biotech industry turns 50 this year, tracing back to a bar conversation that launched Genentech. But while the birthday cake is out, China is running more clinical trials, moving faster through approvals, and closing in on American dominance. The next half-century looks nothing like the first.
Ultragenyx's gene therapy DTX301 hit its Phase 3 primary endpoint in urea cycle disorder, cutting ammonia levels while patients ate more protein and took fewer drugs. One infusion could reshape how families manage a disease where every meal is a risk calculation.
Vistagen lost a Phase 3 trial, watched its stock drop 80%, and just cut 20% of its team. Now it's staking everything on one final trial of its anxiety nasal spray, with results due in months and cash running dangerously low.
Insulet, Abbott, and Dexcom all showed up to the same conference with the same plan: chase the massive, untapped Type 2 diabetes market. The land grab is on, and the stakes couldn't be higher.
The FDA just called out Novo Nordisk for failing to report three patient deaths and at least ten other serious side effects tied to Ozempic, Wegovy, and Saxenda. Some reports were over 800 days late. The drugs aren't the problem; the company's safety reporting system is.
A South Korean biotech with no drugs on the market just drew 839-to-1 institutional demand for its IPO, pricing at the top of its range. Behind the frenzy: a near-billion-dollar licensing deal with a US partner backed by one of biotech's biggest venture firms.
Amgen is subleasing the Horizon Therapeutics R&D hub it envisioned as a rare disease powerhouse, while Evotec axes 800 jobs and four sites. Two very different companies, one uncomfortable truth about biotech's post-COVID reckoning.
A biotech startup wants $91 million to fund a wild idea: genetically engineered bacteria that sneak into pancreatic tumors and activate the immune system from the inside. The Phase 2 data is turning heads, with survival numbers nearly double the standard of care.
An Iran-linked hacking group just hit Stryker, one of the world's largest medical device companies, wiping 200,000 systems and claiming to steal 50 terabytes of data. The attack didn't compromise surgical robots or defibrillators, but it exposes a terrifying vulnerability in the healthcare supply chain.
CRISPR can fix a typo in your DNA. But what about replacing an entire missing gene? A new tool called INSTALL uses a clever immune-evasion trick to insert gene-sized DNA sequences, and it could unlock treatments for thousands of rare diseases that current editors can't touch.
The FDA rejected Capricor's cell therapy for Duchenne muscular dystrophy last summer, citing insufficient evidence. Now the agency has reversed course, lifting its rejection and resuming review with new Phase 3 data in hand. The August 2026 decision could bring the first treatment targeting DMD's deadliest feature: heart failure.
BioNTech's co-founders are leaving the $20 billion company they built to start a brand-new mRNA venture. The stock cratered 20%, no successor has been named, and Wall Street is scrambling to figure out what comes next.
A tiny San Diego biotech spent six years building a molecular glue platform, only to shut down in a field where Big Pharma is pouring billions. The science was hot; the funding wasn't.
AbbVie and Regeneron dropped obesity drug data on the same day, and neither is trying to be the next Ozempic. One showed nearly 10% weight loss in just 12 weeks through a completely different mechanism; the other posted 19% weight loss with dramatically fewer side effects than Zepbound.
ARPA-H just launched the Delphi program to build tiny, Lego-like biosensor "chiplets" that track hormones, inflammation, and medication levels in real time. It could be the biggest leap from Fitbit-grade wellness tracking to actual clinical diagnostics, and researchers have until April 8 to pitch.
The world's biggest drugmakers cut their antibiotic pipelines by 35% in five years, even as superbugs grow deadlier. A new report reveals a dangerous retreat from the drugs modern medicine can't function without.
Takeda's oral psoriasis drug zasocitinib just crushed its Phase 3 trials with biologic-level skin clearance rates. With peak sales estimates of up to $6 billion, the $4 billion acquisition that spawned it might be biotech's best bargain.
BMS's experimental drug mezigdomide just cleared its first phase 3 hurdle in multiple myeloma, validating an entirely new class of cancer drugs called CELMoDs. But the real showdown against the company's own blockbuster predecessor is still a year away.
Join thousands of biotech professionals who start their day with our free, daily briefing.