Original reporting and analysis on the stories shaping biotech.
Boehringer Ingelheim hit the brakes on a Phase 1 trial in Japan just six weeks after it started, citing an unspecified "safety event." The company isn't saying what went wrong, and that silence speaks volumes about the risks lurking in early-stage drug development.
Genentech is dropping $750 million on a new fill-finish facility in Oregon, doubling its Hillsboro campus to churn out prefilled syringes and autoinjectors. It's part of a massive reshoring wave that's reshaping where and how America's injectable drugs get made.
Every pharma company that challenged Medicare's new drug pricing powers has lost in court. Then Teva got something nobody else has: a second chance. The implications for the entire industry could be bigger than the ruling looks.
Doctors overwhelmingly prefer Eli Lilly's Zepbound for weight loss. But Novo Nordisk just dropped a $149 pill, and 74% of GLP-1 patients quit because of cost. In pharma's biggest market battle, the best drug and the best-selling drug might not be the same thing.
The FDA just approved a $2.7 million one-time gene therapy for a rare metabolic disease that previously had zero approved treatments, only cornstarch eaten on a brutal round-the-clock schedule. Ultragenyx's Genglycos could rewrite the playbook for metabolic gene therapy.
BioNTech just unveiled the first-ever data combining a PD-L1×VEGF bispecific antibody with an antibody-drug conjugate in lung cancer. It's a combination nobody has tried before, and it earned a late-breaking oral slot at the world's biggest lung cancer conference.
Bristol Myers Squibb just partnered with a two-year-old AI startup to redesign how it discovers antibodies. Chai Discovery has already landed Eli Lilly, Novartis, and Pfizer as partners, and its AI models are posting hit rates that make traditional screening look ancient.
Amgen just killed a three-year, $500M+ collaboration with TScan Therapeutics aimed at using T-cell receptor therapy to treat Crohn's disease. The move spotlights the growing pains facing the entire TCR therapy space, and leaves TScan with about a year of cash to prove it doesn't need a big pharma partner.
The FDA is reclassifying key oncology diagnostics from Class III to Class II, lowering the barriers that kept competition out of bladder cancer imaging and companion diagnostics. Incumbents like Photocure and Abbott's Vysis brand may soon face a wave of new entrants.
Harvard scientists kept tiny human brain organoids alive for over five years, nearly tripling the old record. The mini-brains didn't just survive; they matured on a human developmental timeline, opening wild new possibilities for studying diseases like Alzheimer's and schizophrenia.
BioMarin is spending $275 million (and up to $490 million total) to acquire a single oral pill that could replace injections for a rare bone disease. The catch: it hasn't proven it works in patients yet.
Jazz Pharmaceuticals is paying up to $1.32 billion for Actio Biosciences and its KCNT1 epilepsy drug, a Phase 1b/2 asset targeting a rare childhood disease with zero approved treatments. It's a massive bet on precision neurology, and the logic behind it reveals where biotech M&A is headed next.
The FDA just approved the first-ever treatment for a disease that literally turns your muscles into bone. Here's why Regeneron's decade-long bet on a radical mechanism matters far beyond the 834 patients it was built for.
Tolerance Bio just signed a $260 million deal with NeoImmuneTech for a thymus-targeting fusion protein, betting that reviving your body's forgotten immune organ could reshape autoimmune and transplant medicine. The thymus has been overlooked for decades; that might be about to change.
An LSD-derived pill just posted the first positive Phase 3 result for any psychedelic-derived anxiety therapy, beating Wall Street expectations with a 5.4-point improvement over placebo. With a second pivotal trial reading out in weeks, the most stigmatized molecule in psychiatry is suddenly knocking on the FDA's door.
J&J paid $245 million for rights to a CAR-T therapy, then quietly handed them back. Now the tiny biotech that made it just got FDA clearance to start U.S. trials, armed with early data that might make you do a double-take.
A boy died in a gene-editing trial for Duchenne muscular dystrophy in August 2025. The company, HuidaGene, didn't tell the public until August 2026, and only after journalists spent months pressing for answers. The case is reigniting fierce debate about transparency in gene therapy.
Trump tapped White House policy adviser Dr. Heidi Overton to lead the FDA, and biotech isn't sure whether to applaud or panic. One analyst called the pick "extremely troublesome" while the agency faces its most complex scientific moment ever.
The FDA just asked the public how it should regulate generative AI medical devices, and the answer could reshape the entire health-tech industry. With AI device authorizations nearly tripling in two years, the clock is ticking on a regulatory framework that doesn't exist yet.
Sandoz just signed a $322 million biosimilar licensing deal with Shanghai Henlius, pushing its pipeline to 39 assets. It's the latest sign that the Swiss giant is building a biosimilar empire, and China is its favorite supplier.
Pfizer just recalled 11 lots of the only drug approved to treat syphilis in pregnant women, and the supply was already in a three-year shortage. With congenital syphilis cases up 700% since 2015, the timing could not be worse.
Eikon Therapeutics raised $381 million in one of 2026's biggest biotech IPOs, then watched its stock open below the offer price. With over $1.1 billion spent and no approved drugs yet, the company's molecular microscopy platform faces its biggest audience: Wall Street skeptics.
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