Original reporting and analysis on the stories shaping biotech.
Filspari just became the first FDA-approved treatment for FSGS, a rare kidney disease that's been without an approved therapy forever. The twist? The pivotal trial technically missed its main goal. How Travere pulled off the approval anyway is a story worth reading.
Eli Lilly's new obesity pill Foundayo logged just 1,390 prescriptions in its first week, sending shares down 2% while rival Novo Nordisk climbed. But history says blockbuster drug launches almost never start with a bang, and the real test comes on April 30.
UK biotech raised over half a billion pounds in Q1 2026, with venture capital surging 17% quarter-over-quarter. But zero companies have gone public. The disconnect between a thriving private market and a dead IPO scene tells a bigger story about where British biotech is headed.
The AKT cancer pathway has crushed more drug developer dreams than any other target in oncology. Now Terremoto Biosciences just raised $108 million to try again, armed with a new chemistry trick and a CEO who already built a $5.8 billion company.
Generate Biomedicines just raised $400 million in the largest biotech IPO since 2024, betting that AI can design better drugs than humans. With a Phase 3 asthma program, a generative biology platform, and the Moderna-incubator Flagship Pioneering behind it, this is the biggest test yet of whether AI drug design can survive public markets.
Roche's new oral pill fenebrutinib cut MS relapses by up to 59% and matched its own blockbuster infusion in progressive disease. But a troubling death imbalance in clinical trials has analysts watching the FDA's next move closely.
The FDA and CMS just announced a new pathway that could compress the six-year wait between breakthrough device approval and Medicare coverage into roughly two months. If it works, it rewrites the playbook for every medtech company chasing reimbursement.
The FDA is planning to reclassify roughly 14 restricted peptides to allow compounding pharmacies to produce them legally. The July 2026 advisory meeting could reshape the peptide market, but the story is more nuanced than the GLP-1 headlines suggest.
Avalyn Pharma wants $200 million to prove that inhaling old lung drugs beats swallowing them. The IPO pitch is elegant, but the early clinical data leaves a big question unanswered.
For 40 years, KRAS was the protein oncologists couldn't touch. Revolution Medicines just showed up at AACR 2026 with clinical data across multiple drugs and tumor types that suggest the "undruggable" era is officially over. Wall Street is already betting big.
Roche deployed over 3,500 NVIDIA GPUs to build pharma's largest AI computing setup, and it's not just a flex. The move signals that GPU-accelerated drug discovery is graduating from pilot programs to full-scale enterprise deployment, with billions of dollars and years of patient waiting on the line.
Alamar Biosciences just pulled off an 11x oversubscribed IPO, raising $191 million for a precision proteomics platform that reads proteins in your blood with absurd precision. Shares jumped 33% on day one, and the debut signals renewed investor appetite for life science tools companies after a brutal 2025.
President Trump signed an executive order telling federal agencies to fast-track psychedelic therapies, and Compass Pathways just got a golden ticket to the front of the FDA's review line. The psychedelic medicine industry went from regulatory purgatory to presidential priority in record time.
Kailera Therapeutics just pulled off the largest biotech IPO in Nasdaq history, raising $625 million and surging 63% on day one. A company that didn't exist two years ago is now worth $3.1 billion, and the story behind it says a lot about where biotech money is headed.
WCG just acquired an AI-powered contract platform called The Contract Network, and it's a window into one of biotech's most overlooked bottlenecks. The unsexy world of clinical trial paperwork is getting a tech-driven overhaul that could reshape how fast drugs reach patients.
Amneal Pharmaceuticals is spending $1.1 billion to acquire Kashiv BioSciences and its four biosimilar manufacturing facilities. In a market racing toward $300 billion in biologic patent expirations, the company that can actually make the drugs might matter more than the company that invented them.
The FDA handed priority review vouchers to three psychedelic therapy developers just six days after a presidential executive order. Compass Pathways, Usona Institute, and Transcend Therapeutics could now see their drugs reviewed in weeks instead of months, marking the biggest regulatory milestone for psychedelic medicine in history.
Helus Pharma's board fired its CEO just two months after hiring him, and they're not saying why. With Phase 3 data on a psychedelic-inspired depression treatment due later this year, the timing couldn't be worse.
Regeneron just landed its first-ever gene therapy approval, and it does something remarkable: restore hearing in children born deaf from a genetic mutation. One surgery, no cochlear implant required. Here's why it matters for a company that built its empire on antibodies.
Pfizer tapped NFL Draft prospect Fernando Mendoza as the face of its cancer screening campaign, and it's not just a feel-good play. Behind the football metaphors is a $43 billion oncology strategy that needs a bigger funnel.
Avalyn Pharma wants $200M+ to prove that two blockbuster lung drugs work better as a mist than a pill. Their IPO lands in a market that's suddenly hungry for exactly this kind of bet.
Regeneron was the 17th and final major drugmaker to cut a pricing deal with the White House's Most Favored Nation initiative. The agreement includes a 58% price cut on Praluent, a free gene therapy for rare childhood deafness, and nearly $10 billion in domestic manufacturing pledges. With 86% of the branded drug market now covered, the real question is what these deals actually mean for patients at the pharmacy counter.
Join thousands of biotech professionals who start their day with our free, daily briefing.