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 ...

As a woman who has succeeded in the STEM industry — most recently at the independent contract development and manufacturing organization (CDMO), Simtra BioPharma Solutions — I’ve learned much about ...

For decades, biotech companies were largely built around a familiar formula: one company, one lead asset, one therapeutic bet. That model produced important medicines, but it also created structural ...

Enrollment success begins long before a patient signs a consent form. As study eligibility criteria grow more complex, sites face increasing pressure to identify qualified participants while managing ...

In ophthalmic trials, operational execution has a direct impact on endpoint quality. Precision assessments often depend on specialized equipment, trained personnel, and strict adherence to visit ...

In this segment from the Life Science Leader Live event “Overcoming Operational Challenges And New Opportunities,” Dr. Ebrahim Delpassand, founder, chairman and CEO at RadioMedix, explains why ...