Original reporting and analysis on the stories shaping biotech.
The FDA has lost roughly 3,500 employees in six months, and biotech companies are racing to scoop up the regulatory talent walking out the door. Former FDA leader Stephen Hahn's jump to Turn Therapeutics is just the latest sign of a brain drain reshaping both the agency and the industry.
AbbVie and Novartis both filed U.S. layoff notices in the same week, continuing a restructuring wave sweeping big pharma. The cuts aren't signs of weakness; they're signs of a much bigger transformation underway.
A Paragon Biosciences spinout just raised $290 million to go after migraine prevention with a totally different approach. The bet: current drugs leave half of patients undertreated, and a protein called PACAP could be the missing piece.
A small French biotech just did what Big Pharma couldn't: get an immunotherapy to work in ovarian cancer. OSE Immunotherapeutics' cancer vaccine Tedopi cut progression risk by 47% in a Phase 2 trial, cracking open one of oncology's most stubborn indications.
The FDA decides on May 29 whether kids as young as four can trade mealtime insulin needles for an inhaler. If approved, Afrezza would be the first needle-free insulin ever cleared for children, and the clinical data is raising eyebrows for all the right (and a few tricky) reasons.
The FDA just delayed its decision on a subcutaneous version of Leqembi that could let Alzheimer's patients skip 39 IV infusions entirely. The three-month pushback to August 2026 matters more than it sounds, because the biggest barrier to Leqembi's success isn't the science; it's getting patients to show up.
A Chinese-made antibody-drug conjugate just supercharged Keytruda in a landmark lung cancer trial, cutting the risk of progression by 65%. It's the first ADC-immunotherapy combo to win in frontline lung cancer, and it could reshape Merck's entire post-patent strategy.
Eli Lilly's retatrutide, a triple gut-hormone agonist, just posted Phase 3 weight loss numbers that rival bariatric surgery: nearly 29% body weight gone in 80 weeks. The obesity drug race just got a new frontrunner, and the competition is scrambling.
Prediction markets are letting people bet real money on clinical trial outcomes and FDA decisions. The potential for cleaner investing signals is real, but so are the insider trading risks and ethical landmines that come with gambling on whether a drug will save lives.
A tiny, pre-clinical biotech just agreed to buy an AI-driven CAR-T startup for $320 million in stock. The science is fascinating, but the deal structure is raising eyebrows across the industry.
Eli Lilly just paid up to $202 million for a startup with zero products, zero revenue, and zero clinical trials. The reason? A tiny fat bubble called Tethosome that might solve gene therapy's hardest problem.
Psychiatry diagnoses schizophrenia and bipolar disorder the same way it did 50 years ago: by talking and guessing. A tiny California company just got FDA fast-track status for a blood test that claims 98.3% accuracy in telling the two apart.
Biogen and Denali's LRRK2 inhibitor nailed every biological target in a 648-patient Parkinson's trial, then failed to help a single clinical measure. A billion-dollar partnership just lost its centerpiece, and the implications ripple across the entire field of neurodegeneration.
Isomorphic Labs, the Google DeepMind spinoff, just raised $2.1 billion in the largest AI drug discovery financing ever. With Nobel Prize-winning science, $3 billion in pharma deals, and zero approved drugs, the company is making the biggest bet the field has ever seen.
A Suzhou biotech just raised $80 million on the Hong Kong Stock Exchange to fight bacterial infections, an area most investors won't touch. Its lead drug crushed the standard of care for H. pylori in Phase III, and the company's hybrid chemistry platform could reshape how we treat everything from stomach bugs to infected hip implants.
Novartis is cutting research staff despite posting $13.1 billion in quarterly revenue and seeing its top drugs grow by double digits. The reason reveals a massive shift in how Big Pharma thinks about where innovation should come from.
Pharma companies have pledged a jaw-dropping $292 billion to build U.S. factories in just six months, driven by tariff threats that could double the cost of imported drugs. The numbers are historic, but turning promises into actual plants is a whole different game.
A 67-year-old man lived nine months on a gene-edited pig kidney before it was removed, and eGenesis just got FDA approval to take the technology much further. Nearly 100,000 Americans on the kidney waitlist are watching closely.
Moderna and Merck just finished enrolling their pivotal Phase III trial for a cancer vaccine custom-built from each patient's tumor DNA. The Phase IIb data already showed a 49% reduction in cancer recurrence at five years, and now the real test begins.
Faeth Therapeutics just posted an 80% response rate in endometrial cancer by starving tumors of their metabolic fuel. Their secret weapon? A drug combo that shuts down the PI3K pathway at three points, paired with a prescribed diet that cuts off the supply lines.
Pathos AI used its algorithm to scan thousands of datasets, flag a promising Belgian cancer drug, and acquire the company behind it. It's one of the first clinical-stage oncology deals sourced entirely by AI, and the early data on the drug itself is turning heads.
Bristol Myers Squibb is deploying Anthropic's Claude AI to more than 30,000 employees across every major function, from drug discovery to the sales force. It's the biggest enterprise AI bet in pharma, and BMS is racing a $15 billion patent cliff to prove it works.
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