Original reporting and analysis on the stories shaping biotech.
The FDA's biologics center just lost its fifth director in a little over a year. Vinay Prasad's exit leaves CBER in limbo at a moment when gene therapies, cell therapies, and vaccines hang in the balance, and analysts are warning of months of regulatory volatility ahead.
The FDA just approved the first-ever PROTAC, a drug that doesn't just block cancer proteins but destroys them entirely. Vepdegestrant's approval for ESR1-mutated breast cancer validates an entirely new class of medicine, and the implications stretch far beyond one tumor type.
Two Oxford companies are teaming up to decode the genetic roots of autoimmune disease, and their bet could reshape how drug targets are chosen. Genomics Ltd. brings the world's largest gene dataset; Greywolf Therapeutics brings the clinical candidates. The result might just fix your immune system's friendly-fire problem.
The FDA just proposed keeping liraglutide off the 503B Bulks List, potentially blocking compounding pharmacies from making cheaper versions of Saxenda and Victoza at scale. With semaglutide and tirzepatide getting the same treatment, the entire compounded GLP-1 market is under threat.
Merck's islatravir was sidelined in 2021 after tanking patients' immune cells. Four years later, the FDA just approved it as part of a new two-drug HIV pill. The comeback story is wild.
Bristol Myers Squibb just ended an eleven-year bispecific antibody partnership with Zymeworks, torching $313 million in potential milestones. But the real story is what BMS's ruthless portfolio purge tells us about where big pharma is placing its bets.
An FDA advisory panel voted 6-3 against AstraZeneca's plan to use blood tests to trigger early breast cancer drug switches. The rejection challenges the entire premise of preemptive, biomarker-driven therapy and reshapes the oral SERD race.
J&J axed its CAR-T lymphoma program despite data that embarrassed the competition, complete response rates that made Yescarta look like last season's model. The real story isn't about science; it's about the brutal economics threatening the entire cell therapy space.
Indivior's experimental opioid addiction drug flopped in Phase 2, and now the company is gutting its research team. Wall Street didn't flinch, but the long-term implications of becoming a one-drug company are harder to ignore.
LEO Pharma just paid $50 million for a company that turns herpes simplex virus into a gene therapy delivery system for devastating skin diseases. It's preclinical, it's audacious, and it might be the future of dermatology.
The FDA just approved the first small-molecule GLP-1 pill for obesity, and it might matter more for who it reaches than how much weight it drops. Eli Lilly's Foundayo could unlock the half of eligible patients who refused to pick up a needle.
Amgen axed two clinical programs in the same week after Phase 2 disappointments, one in lung cancer and one in Sjögren's disease. The dual failures spotlight pharma's toughest development stage and raise questions about pipeline depth at a $35 billion company.
AstraZeneca just paid $25 million to license a cancer drug that doesn't block tumor proteins, it destroys them completely. The preclinical EGFR degrader from Pinetree Therapeutics could rescue patients who've run out of options on current treatments.
AstraZeneca faces an FDA advisory committee today with two precision oncology drugs that posted solid trial numbers. The problem: FDA reviewers think neither drug has clearly answered the questions that matter most.
Teva drops $700 million on Emalex Biosciences to grab ecopipam, the first new Tourette syndrome drug mechanism in over 50 years. After a decade of paying off debt and sitting out the M&A party, the generics giant is making its boldest neuroscience bet yet.
Avalyn Pharma planned to raise $182 million in its IPO. It walked away with $300 million instead, pricing at the top of the range for its inhaled lung disease drugs. The biotech IPO market is back, and investors are hungry.
BeOne Medicines just committed up to $2 billion for a trispecific antibody that hasn't been tested in humans. The deal signals pharma's increasingly aggressive bets on next-generation multispecific drugs, and the option structure reveals a masterclass in managing preclinical risk.
The FDA slammed the brakes on Newron Pharmaceuticals' Phase 3 schizophrenia trial after a patient died at a non-U.S. site. The company says the drug isn't to blame, but the agency wants proof. For one of the few novel approaches to treatment-resistant schizophrenia, the clock is ticking.
GSK and Alector just killed their second Alzheimer's trial in six months, effectively torching a $700 million partnership. The failure raises uncomfortable questions about whether targeting the brain's immune system can actually slow neurodegeneration.
Chiesi just dropped $1.9 billion on KalVista to grab the only oral pill for acute hereditary angioedema attacks. In a week with five biotech acquisitions, this bet on needles going extinct in HAE might be the smartest of the bunch.
AstraZeneca pulled the plug on atuliflapon after its phase 2 asthma trial flopped on efficacy. The drug joins a long, inglorious list of FLAP inhibitors that have never made it to market, raising hard questions about whether this entire drug class is a dead end.
Teva just dropped $700 million on a Tourette syndrome drug that works completely differently from anything on the market. After 50 years without a new approved treatment, ecopipam could finally break the drought.
Join thousands of biotech professionals who start their day with our free, daily briefing.