Original reporting and analysis on the stories shaping biotech.
BioMarin's $270 million acquisition of Inozyme Pharma just hit a wall: the lead drug raised the right biomarker but couldn't heal children's bones in a Phase 3 trial. Now the deal's entire thesis is in question, and a write-down looks increasingly likely.
Evaluate's new forecast says global drug sales will double to $2 trillion by 2032, powered by GLP-1 obesity drugs and inflammation therapies. But Wall Street has already started cutting its estimates, and the pricing math might not add up.
The FDA just approved a $425,000-a-year kidney disease drug from a company that didn't even exist under its current name five years ago. TRUTAKNA's accelerated approval is only half the story; the data that could make or break it arrives in weeks.
AstraZeneca signed a $2.1 billion licensing deal with Sino Biopharmaceutical for a COPD drug designed to challenge Merck's blockbuster Ohtuvayre. With stronger early lung function data and AstraZeneca's massive respiratory salesforce behind it, the PDE3/PDE4 market just became a two-horse race.
Bristol Myers Squibb just crushed Q2 estimates and hiked its 2026 forecast by billions, thanks to a blood thinner that won't quit and a new drug lineup firing on all cylinders. There's just one problem: the biggest patent cliff in pharma history is about 18 months away.
A tiny German biotech just got approval to test the first non-viral CAR-T therapy in humans, targeting leukemia with a manufacturing approach that costs a fraction of the industry standard. If it works, it could blow open who gets access to cell therapy.
Scientists at the University of Minnesota assembled a cell entirely from non-living parts that can eat, grow, copy its DNA, and divide. It runs for about five to ten generations before breaking down, and its creators are clear: they haven't created life. But they may have built the most important chemistry set in history.
RFK Jr. wants to create a federal catalog of presumed Covid-19 vaccine injuries, a move that could help legitimately harmed patients or validate scientifically unsupported claims. The proposed rule drops in November, and everyone from Wall Street to the CDC is bracing for the fallout.
Fate Therapeutics' off-the-shelf CAR-T therapy just showed early promise in systemic sclerosis, a brutal autoimmune disease with no real cure. Only four patients so far, but every one improved — with zero serious side effects.
An FDA advisory panel voted 9–3 against Capricor's deramiocel for Duchenne heart disease, citing "fragile" data and suspicious statistical changes. With the PDUFA decision three weeks away, the odds of approval just got a lot worse.
After three FDA rejections and a dramatic appeal that went over the review division's head, Outlook Therapeutics' Lytenava just became the first FDA-approved ophthalmic bevacizumab for wet AMD. Now comes the harder part: selling it in an $8.5 billion market where doctors have used the off-label version for decades.
Calliditas just proved a brand-new class of drugs can fight liver disease by targeting oxidative stress at its enzymatic source. The Phase 2b data are in, the mechanism is validated, and the competitive landscape is wide open.
Researchers found inherited genetic markers that predict who'll face the worst side effects from CAR-T therapy, potentially enabling pre-treatment screening. The findings could reshape how doctors prepare patients for one of oncology's most powerful (and volatile) treatments.
Roche killed two Huntington's disease programs on the same day, including the long-running tominersen partnership with Ionis. The drug lowered the toxic protein beautifully; it just didn't help patients. For a disease that's now racked up a half-decade of high-profile failures, the pipeline has never been wider or more uncertain.
CDER has lost over 1,000 employees since early 2025, cycled through five directors, and faces a growing pile of complex drug applications with zero new user-fee hires in 2026. The FDA's drug review engine is still running, but the cracks are getting harder to ignore.
Eli Lilly is spending up to $3.8 billion to acquire AtaiBeckley, a psychedelic-medicine company with a nasal spray for treatment-resistant depression. It's the largest pharma acquisition ever for a psychedelic-mechanism drug, and Wall Street says it changes everything for the field.
The FDA convened an advisory panel to review Capricor's deramiocel, a first-of-its-kind cell therapy for Duchenne muscular dystrophy heart disease. There's just one problem: the agency's own scientists say the evidence doesn't prove it works.
Sanofi axed amlitelimab, the $1.1B next-generation eczema drug that was supposed to succeed its $11.6B blockbuster Dupixent. The problem? It wasn't actually better. Now Sanofi's post-Dupixent immunology strategy has a gaping hole and a ticking patent clock.
Pfizer just recalled lots of the only drug recommended to treat syphilis in pregnant women, compounding a shortage that's already lasted years. With congenital syphilis cases at historic highs, public health officials are calling it a preventable tragedy in slow motion.
GSK beat Q2 estimates, then dropped a $2.5 billion restructuring bomb designed to save £1.9 billion a year by 2029. The real story? It's all about surviving the 2028 patent cliff on its blockbuster HIV drug, and GSK just doubled its Phase 3 trial starts to get there.
Kailera's oral obesity pill delivered ~11% weight loss in a late-stage China trial, but roughly 70% of patients experienced nausea and 67-69% had vomiting. With Novo Nordisk and Eli Lilly dominating the oral obesity market, Kailera's GI problem could be a dealbreaker.
For 40 years, scientists called the RAS protein "undruggable." Now the FDA is fast-tracking the first drug to block it across multiple mutations, and its pancreatic cancer survival data are unlike anything oncologists have seen before.
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