Original reporting and analysis on the stories shaping biotech.
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.
Eikon Therapeutics just pulled off the largest biotech IPO in two years, raising $381 million on a platform that literally watches individual proteins move inside living cells. With Nobel Prize co-founder Eric Betzig and former Merck R&D chief Roger Perlmutter at the helm, the company is betting its cancer pipeline (and a billion-dollar war chest) on seeing biology differently.
The FDA just proposed letting biosimilar developers skip expensive U.S.-only comparison studies, potentially saving $20 million per program. Combined with other recent reforms, this could cut total development costs in half and reshape competition for blockbuster biologic drugs.
J&J's nipocalimab just scored its fifth FDA Fast Track designation, this time for lupus. It works by blocking the receptor that keeps harmful autoantibodies alive, and the Phase 2 data suggest it could finally help patients escape the steroid trap that defines current treatment.
Generate Biomedicines just pulled off the biggest biotech IPO of 2026, raising $400 million on an AI platform that designs drugs nature never imagined. The stock promptly dropped 20% on day one. So is this a breakthrough or a bubble?
Vistagen's stock once surged 1,272% on a single trial result, then cratered 80% when the next one flopped. Now the company has cut 20% of its staff and is betting everything on one final Phase 3 readout that could save or sink the whole operation.
Pfizer went from signing a $1.25 billion deal with China's 3SBio to Phase 3 readiness in just six months, an almost unheard-of pace for a licensed oncology asset. The drug, SSGJ-707, is part of a $40 billion industry-wide scramble to own the PD-1/VEGF bispecific space before the immunotherapy patent cliff hits.
Inovio Pharmaceuticals just slashed its workforce to 112 people and bet the entire company on a single FDA decision for INO-3107. With $58.5 million in cash, a skeptical FDA, and an October deadline, there's almost no room for error.
Immutep's stock cratered roughly 90% after an independent committee pulled the plug on its most important lung cancer trial. The failure raises tough questions about a once-promising immunotherapy approach and adds to a brutal streak of late-stage clinical disasters.
Vertex dropped $4.9 billion on a kidney drug most people had never heard of. Two years later, the Phase 3 data just landed, and it's turning heads across the IgA nephropathy space. The stock hit a record high.
A single FDA departure sent gene therapy stocks soaring, with uniQure jumping 26% in one day. Vinay Prasad's exit from CBER after a chaotic 10-month tenure has the entire genetic medicines sector recalculating its odds.
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.
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