FDA’s OPDP untitled letters show rising scrutiny of DTC ads’ overall impression on consumers and urge companies to balance ...

FDA’s draft “plausible mechanism” framework gives individualized genetic therapies a clearer path to market, but questions remain, write experts at Morrison Foerster.

As emerging biotechs scale, procurement is becoming a key lever for patient access, resilience, and long-term commercial ...

The global pharmaceutical supply chain has been under intense scrutiny since the COVID-19 pandemic exposed its heavy reliance on concentrated Active Pharmaceutical Ingredient (API) manufacturing hubs.

Achieving regulatory approval for a new drug is an extraordinary achievement. The bar for success is high. Many companies with breakthrough scientific discoveries and promising clinical data still ...

I spent years prosecuting traffickers of street drugs like meth and fentanyl, but the drug crisis that should most concern life sciences companies is a less visible illicit drug market: one that ...

Biotech has entered a new era of financial discipline. The days of easy capital, billion-dollar preclinical valuations, and “platform first, data later” investing have largely disappeared. Today, ...

GLP-1s didn’t just change how patients lose weight. They changed how pharma must sell. GLP-1 receptor agonists were supposed to be a diabetes treatment. Instead, they became the first pharmaceutical ...

Drug and device manufacturers have long sought clearer rules for sharing scientific information about unapproved (off-label) uses of their products with health care providers (“HCPs”). In January 2025 ...

The era of outsourced regulatory work and rented thinking is ending. Agentic AI makes in-house capability inevitable, if leadership has the nerve to build it. Every biopharma CEO now claims to run an ...

As life sciences companies move from the laboratory to the market, the relationship between the commercial leader and the board becomes both more complicated and more consequential. When it works well ...