Original reporting and analysis on the stories shaping biotech.
The FDA's new oncology chief just laid out his game plan: hire more reviewers and bring AI into cancer drug reviews. With the agency's oncology division bleeding staff and approvals already slipping, the clock is ticking.
A brand-new biotech just walked out of stealth mode with $225 million and a plan to crack one of cancer's coldest, most stubborn problems. Solstice Oncology is betting a next-gen antibody can succeed where checkpoint inhibitors have stalled.
AstraZeneca's breast cancer pill camizestrant won FDA approval on September 4. Eight days later, it failed the primary endpoint in its biggest clinical trial. The drug keeps its niche, but the blockbuster dream just got a lot harder.
The FDA just approved the first SMA drug that ignores the broken gene entirely and goes straight to the muscle. Scholar Rock's Isembyld succeeded where a generation of myostatin inhibitors failed, and the story of how is more interesting than you'd expect.
The FDA just pushed back its decision on Exelixis' colorectal cancer combo by three months, and analysts are surprised. With tightening regulatory standards for combination oncology drugs and a crowded competitive landscape, the stakes of this delay go well beyond one company's pipeline.
The FDA commissioner reportedly tried to block approval of KalVista's rare disease drug, but senior scientists pushed back and the request was withdrawn. The episode raises uncomfortable questions about where political influence ends and scientific review begins at America's top health agency.
A federal court just blocked generic Spravato until 2035, handing J&J a decade of exclusivity on a drug headed toward $5 billion in peak sales. For generics companies, the ruling is a costly warning shot.
Moderna and Merck's personalized mRNA cancer vaccine just became the first of its kind to win a Phase 3 trial, and the entire biotech industry is rethinking what's possible. The catch? Every single dose has to be built from scratch for each patient.
Sarepta slapped a black box warning on its flagship Duchenne gene therapy after two children died of liver failure, then cut 36% of its workforce. The crisis isn't just about one company; it's exposing a safety problem that haunts the entire AAV gene therapy field.
Biotech startups are ditching the traditional IPO and flooding into reverse mergers at record pace, with roughly two dozen deals and $2 billion in financing so far in 2026. But the supply of clean shell companies is running thin, and regulators are tightening the screws.
Kailera's oral obesity pill delivered ~11% weight loss in Phase 3, but roughly 70% of patients experienced nausea. With Novo Nordisk and Eli Lilly racing ahead with better-tolerated oral pills, Kailera faces a tough question about whether efficacy alone is enough.
A small CAR-T trial just went 20-for-20 in wiping out precancerous cells in patients at high risk for multiple myeloma. Zero progression, zero serious side effects. It's the first real evidence that cell therapy might prevent cancer, not just treat it.
Biohaven inked a deal worth up to $795 million for its epilepsy drug opakalim. Nine days later, the FDA placed a partial clinical hold on the program over rodent findings. The timing is a masterclass in biotech's most unpredictable risk.
An oncology company just spun out a diabetes startup with $50 million and Eli Lilly's backing. Kura Oncology's creation of Caspian Therapeutics is one of the most creative dealmaking moves of the year, and the science behind it is surprisingly logical.
AbbVie's migraine pill just aced a Phase 3 trial in menstrual migraine, a condition affecting millions of women that has never had a dedicated preventive treatment. In a crowded CGRP market, this might be the smartest niche play in neurology.
Andy Plump spent eleven years turning Takeda into big pharma's most prolific biotech matchmaker, racking up 200+ partnerships and a rebuilt pipeline. Now he's retiring, and the industry he helped reshape is watching to see if the model survives without its architect.
Frazier Life Sciences just closed $1.1 billion for its public biotech fund while early-stage startups can barely get a meeting. Welcome to biotech's barbell market, where the money is plentiful but only flows in one direction.
A major Novartis shareholder is demanding a board overhaul after back-to-back trial failures and a record stock drop. When your $12 billion acquisition produces a drug that flunks its biggest test, someone has to answer for it.
BridgeBio Oncology pulled its lead KRAS drug out of the lucrative first-line lung cancer race, shrinking from a 200,000-patient opportunity to roughly 50,000. The stock dropped 24% in a single session, and the competitive fallout is just getting started.
BMS's new GPRC5D-targeting CAR-T therapy met all its pivotal trial endpoints in multiple myeloma. But in an unusual move, the company refused to share the actual response rates. In a crowded CAR-T race, what you don't say can be louder than what you do.
Evommune's eczema drug EVO756 just failed its second mid-stage trial this year, effectively killing an entire drug target that attracted hundreds of millions in investment. Two swings, two misses, and now every other company chasing MRGPRX2 has a credibility problem.
Novartis signed a deal worth up to $3.22 billion with South Korean biotech Alteogen to convert IV infusion drugs into quick subcutaneous shots. It's the biggest delivery-platform bet in the company's history, and it puts Novartis squarely in the middle of pharma's hottest arms race.
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