Original reporting and analysis on the stories shaping biotech.
The FDA just approved the first-ever CELMoD therapy, a next-generation twist on one of cancer medicine's oldest tricks. Bristol Myers Squibb's iberdomide could reshape both the myeloma treatment landscape and the company's financial future.
The UK is pouring £250 million into a new biosecurity research centre in Harlow, Essex, but it won't be fully operational until 2038. With life sciences FDI down 58% and a looming talent shortage of 133,000 workers, the real question is whether the money arrives fast enough to stop the bleeding.
Lantheus' MK-6240 tau PET brain scan just hit its FDA decision date, and it could change how doctors pick which Alzheimer's patients actually benefit from new treatments. Think of it as upgrading from a blurry X-ray to an HD camera, right when the field needs it most.
Eli Lilly is slashing Zepbound prices to as low as $449/month through direct-to-consumer vials, targeting the millions of cash-paying patients currently tempted by a booming (and dangerous) black market for GLP-1 drugs. It's part pricing strategy, part public health play, and entirely about protecting a $13.5 billion franchise.
The last Lyme disease vaccine was killed by lawsuits, not science. Now Pfizer and Valneva's new candidate just hit a major regulatory milestone in Europe, and this time the stakes (and the tick populations) are much bigger.
Vertex just agreed to buy Crinetics Pharmaceuticals for $10 billion in cash, its largest acquisition ever and a bold bet on the endocrinology market. With a commercial drug already generating revenue and a pipeline that could hit $5 billion in peak sales, this deal reshapes Vertex's future beyond cystic fibrosis.
Gilead just paid $2.2 billion for a startup that's barely a year old, with one drug and no pivotal data. The Ouro Medicines deal reveals Gilead's aggressive push into autoimmune disease, and a clever cost-sharing trick that cuts the risk in half.
EGFR exon 20 insertion mutations have been one of lung cancer's most stubborn puzzles, resisting nearly every targeted drug thrown at them. Now zipalertinib just posted a positive Phase 3 readout that could reshape how doctors treat this rare mutation from day one.
CRISPR's scissors work great. The problem is that different cells repair the cuts in wildly different ways. Researchers have now identified specific genes, led by a troublemaker called TREX1, that actively sabotage editing efficiency, and the discovery could reshape how we pick patients and design gene therapies.
Three biotech companies raised over $1.2 billion in a single day, with Braveheart Bio leading the charge at $440 million. It's the strongest signal yet that biotech's IPO drought is officially over.
China built the world's fastest clinical trial machine. Now it's adding guardrails, while the U.S. scrambles to speed up. The regulatory collision reshaping global drug development is here.
Novo Nordisk just made AWS its preferred cloud partner and opened a joint innovation hub in London to turbocharge drug discovery with AI. It's the latest (and maybe most ambitious) move in pharma's cloud arms race, but the real question is whether AI can actually deliver faster drugs or just faster press releases.
Eli Lilly just sued six companies for selling its experimental obesity drug retatrutide on the black market, and the drug isn't even FDA-approved yet. The lawsuits reveal a booming underground trade that Lilly says spans 14,000 flagged listings across 100+ countries.
The first-ever drug for the relentless hunger of Prader-Willi syndrome is under scrutiny after seven deaths and over 100 serious adverse events surfaced in post-marketing reports. Experts aren't saying pull it; they're saying pay closer attention.
Novartis spent years publicly dismissing antibody-drug conjugates, only to drop $1.1 billion on a UK startup whose lead drugs haven't been tested in humans. The Myricx Bio acquisition is either a brilliant platform play or one of the most expensive science experiments in recent pharma history.
J&J just locked in an exclusive option to buy Sail Biomedicines for $2.58 billion, dropping $785 million upfront on a company building technology to reprogram your immune system from the inside. It's the pharma giant's biggest bet yet that in vivo CAR-T could reshape immunology.
STAT News is asking why MoonLake Immunotherapeutics won't show its homework after announcing "positive" Phase 3 results. For a stock that's fallen 65% in a year, the silence is deafening.
Akeso's ivonescimab just grabbed its third lung cancer approval in China in two years, and an FDA decision is only months away. This two-in-one bispecific antibody is gunning for Keytruda's throne, and Wall Street can't decide whether to cheer or hedge.
Zydus's U.S. subsidiary just inked a deal worth up to $475 million for a rare lung disease drug most people have never heard of. The option-and-license structure, the Indian pharma giant's quiet rare disease shopping spree, and what still needs to go right make this one worth watching.
Pharma companies have pledged roughly $500 billion to build factories, labs, and manufacturing plants across the U.S. as 100% tariffs on imported drugs kick in. It's the biggest reshoring wave the industry has ever seen, but will it actually change anything?
Definium Therapeutics just nailed its second Phase 3 anxiety trial with an LSD-derived drug that works after a single dose. Back-to-back wins in a therapeutic area that hasn't seen a new drug class in decades have Wall Street and patients paying very close attention.
ITM Isotope's cancer drug crushed its Phase 3 trial, delivering nearly 10 extra months of progression-free survival. The FDA rejected it anyway, citing manufacturing problems. It's a cautionary tale the entire radiopharmaceutical sector needs to hear.
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