Original reporting and analysis on the stories shaping biotech.
Intuitive Surgical recalled stapler cartridges for its da Vinci robot after one patient death and four serious injuries, all caused by a glitch where the system told surgeons the staples fired correctly when they hadn't. The fallout could reshape how the FDA monitors the fast-growing robotic surgery market.
CAR-T cell therapy was invented in America, but China now runs more clinical trials and enrolls patients twice as fast. With U.S. research funding under pressure and China's R&D spending pulling even, the global biotech balance of power is shifting faster than most people realize.
MiniMed just got FDA clearance for the Flex, an insulin pump that's half the size of its predecessor and has no screen at all. In a market dominated by Insulet's tubeless Omnipod, this is MiniMed's boldest move yet to prove it can compete on lifestyle appeal.
Embecta, the century-old insulin syringe giant, just dropped $200 million on a UK auto-injector maker called Owen Mumford. It's the clearest signal yet that the company wants to be something much bigger than needles.
Vinay Prasad's ten-month tenure atop the FDA's biologics division was defined by drug rejections, staff clashes, and a brief firing. His exit could reshape how fast new gene therapies and vaccines reach patients.
Immutep's stock lost nearly 89% of its value in a single morning after regulators pulled the plug on its flagship Phase 3 lung cancer trial. A 15-year bet on a novel immunotherapy approach just hit the wall.
The FDA just approved the first-ever transcatheter device specifically designed for aortic regurgitation, a leaky heart valve condition that's had no dedicated interventional treatment until now. JenaValve's Trilogy system beat every benchmark the FDA set, and cardiologists are calling it a new standard of care.
The FDA just approved the first oral peptide that targets the IL-23 pathway for plaque psoriasis, delivering biologic-level skin clearance in a once-daily pill. ICOTYDE could reshape how millions of patients manage their disease, and a $7 billion market along with it.
Crossbow Therapeutics just banked $77 million from Taiho Ventures, Pfizer, and Eli Lilly for antibodies that can see inside cancer cells. Their Phase 1 is already running, and the data readout is months away.
A stealth biotech just raised $77.5 million to replace the chalky, metallic pills that dialysis patients choke down 10 times a day. The investors fighting to get in include some of the biggest names in kidney care, and the science behind AP306 is unlike anything currently on the market.
Bicycle Therapeutics just axed 30% of its staff and shelved its most promising cancer drug after the FDA rejected the trial as an approval path. The pivot to radioconjugates is bold, but can a company rebuild its identity around earlier-stage assets?
Gossamer Bio's lead PAH drug missed its Phase 3 goal by the thinnest statistical margin imaginable. Now 77 employees are out, the stock is down 80%, and the company is fighting for survival with $137 million and a prayer.
For decades, patients with primary biliary cholangitis had treatments for their failing livers but nothing approved for the relentless itch that ruined their sleep and quality of life. The FDA just changed that with a first-of-its-kind approval that validates an entirely new mechanism of action.
A Japanese biotech with molecular mimicry tricks teams up with an AI startup to go after "undruggable" protein targets, starting with obesity. Their bet: that smart chemistry plus smarter computation can crack what brute-force screening never could.
The FDA lost over 4,000 staffers, burned through five drug division chiefs in a single year, and watched approvals slip. Now biotech companies are starting to look overseas, and investors are getting nervous.
Johnson & Johnson is closing its New York JLABS incubator, the fourth shutdown in a year. With $32 billion deployed on deals and acquisitions instead, J&J's message to early-stage startups is clear: we'd rather buy the winners than grow them.
A senator says GSK pulled a vanishing act with one of America's most common asthma inhalers, swapping the brand name for a copycat to dodge Medicaid penalties. Nearly 5 million kids got caught in the middle, and Congress wants answers.
Bicycle Therapeutics gutted its lead cancer drug, cut 30% of staff, and is betting what's left on a backup candidate with its own baggage. The company that pioneered bicycle toxin conjugates just learned that inventing a category doesn't guarantee you'll win in it.
Aldeyra Therapeutics just received its third FDA rejection for dry eye drug reproxalap, with regulators once again citing inconsistent efficacy data. The stock plunged over 70%, and Wall Street is running out of patience for a drug that keeps failing the same test.
J&J just got FDA approval for the first oral pill that rivals injectable biologics in clearing psoriasis. ICOTYDE beat the only other oral option head-to-head, and it's gunning for three more diseases next.
Eli Lilly and Roche dropped nearly $1 billion on South Korea's biotech sector in the same week. When two pharma giants race to plant their flags in the same country, it's worth asking what they see that the rest of us don't.
CytomX's stock rocketed 60% after its "masked" cancer drug posted surprising response rates in colorectal cancer patients who'd run out of options. The same day, Astellas walked away from a $1.6 billion partnership. One door closes, another blows off its hinges.
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