Original reporting and analysis on the stories shaping biotech.
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.
The FDA quietly stopped publishing drug rejection letters after an anonymous pharma company challenged the practice. Investors, clinicians, and small biotechs are losing a critical window into why drugs fail, and October's deadline could determine whether it ever comes back.
Vertex Pharmaceuticals is paying $10 billion (a 102% premium) to acquire Crinetics Pharmaceuticals, its largest deal ever, betting big on hormone disorder drugs it says could generate $5 billion in annual revenue. Analysts are split on whether the price is genius or excessive.
Zymeworks is spending $929 million to buy Theravance Biopharma, a company whose lead drug failed twice in late-stage trials. The real prize isn't the drug; it's a portfolio of royalty cash flows that reveals where biotech M&A is really headed.
Novo Nordisk just launched the world's first once-weekly insulin in a country with 100 million diabetics, and it's actually cheaper than the daily alternatives. India could be the ultimate test case for whether convenience can fix the global insulin adherence crisis.
Moderna launched a 4,000-person Phase 3 trial for its mRNA bird flu vaccine, and interim data already show 82.7% efficacy against H5N1. With avian flu infecting over 1,000 dairy herds and jumping into dozens of mammal species, this is pandemic prep before the pandemic.
Roche killed two Huntington's disease programs on the same day, ending a 13-year bet with Ionis that the right biomarkers would lead to the right treatment. They didn't. Here's what it means for patients running out of options.
Dr. Reddy's was supposed to flood the market with cheap semaglutide pens. Then an impurity showed up during scale-up, cutting its volume target in half and wiping $678 million off its market cap. The GLP-1 generic revolution just got a harsh lesson in peptide manufacturing reality.
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