Original reporting and analysis on the stories shaping biotech.
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.
Vertex Pharmaceuticals just filed for FDA approval of a kidney disease drug that could bring in $4 billion a year. After two decades as the cystic fibrosis company, Vertex is making its boldest move yet to prove it can be something bigger.
Kerendia just became the first drug to post five consecutive Phase III wins across kidney and heart disease populations. Bayer's latest trial success could unlock a massive new patient population, and the company's turnaround plan is banking on it.
A new biotech just debuted with $78 million and a plan to replace the pill-heavy standard of care for dialysis patients. R1 Therapeutics is betting that blocking phosphate at the source beats trying to mop it up, and some of the biggest names in kidney care are backing the play.
Idorsia's CEO lasted just nine months before departing by "mutual agreement," sending shares tumbling and marking the Swiss biopharma's third leadership change in under two years. Founder Jean-Paul Clozel is back as interim CEO, but the turnaround clock is ticking.
Sarepta's $3.2 million Duchenne gene therapy has been linked to fatal liver failure. Now the company is testing whether adding a second immune-suppressing drug can fix the problem and reopen treatment to the patients who need it most.
Pfizer's next-gen cancer drug atirmociclib just aced a Phase 2 trial in breast cancer, cutting disease progression risk by 40%. With Ibrance's patent cliff looming, this selective CDK4 inhibitor could be Pfizer's plan to replace its own $14.6 billion blockbuster class.
Amplifon just dropped €2.3 billion to buy the company that makes the hearing aids it sells, creating a vertically integrated giant in one of medtech's fastest-growing markets. The deal reshapes an entire industry, and the competition should be worried.
The FDA just dropped guidance that could cut biosimilar development costs by $20 million per product and slash timelines by years. It's the second big regulatory swing in six months, and it could reshape who gets to compete in the $192 billion biologics market.
A single Type 1 diabetes patient has been producing their own insulin for 14 months after receiving engineered cells in their forearm, with zero immunosuppressive drugs. Sana Biotechnology's tiny experiment could reshape the race for a diabetes cure.
Akeso just sent the world's only trispecific antibody targeting ILT2, ILT4, and CSF1R into human trials. If one drug that hits three immune targets at once can turn cold tumors hot, it could rewrite the rules of cancer immunotherapy.
The FDA just approved Vanda's Bysanti for schizophrenia and bipolar I, but here's the twist: your body converts it right back into the company's older drug. Is this clever lifecycle strategy or a $20 billion market remix that could save a struggling company?
The FDA just approved the first-ever targeted therapy for arginase 1 deficiency, an ultra-rare disease that previously had zero approved treatments. For roughly 250 Americans living with ARG1-D, this changes everything.
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