Attention around pharmacovigilance transformation potential has tended to focus on automating discrete steps in the ...

As Eli Lilly moves forward with its $3.5 billion injectable medicines facility in the Lehigh Valley region of Pennsylvania, ...

Oncology remains the leading M&A magnet, with ASCO data catalyzing interest in new combinations and next-generation ...

FDA authorized the first generic baloxavir marboxil, a cap-dependent endonuclease inhibitor, expanding single-dose influenza antiviral access and introducing a new competitor to the branded product ...

At CPHI Americas 2026, PharmTech spoke with Dr. Molly Klote, president and CEO, Klote Medical Research Advisors, and ...

Eli Lilly was attracted by a deliberately cultivated life sciences strategy anchored in a region where manufacturing ...

The US Pharmacopeia’s 2025 annual drug shortages report found that while the total number of shortages declined by 23% in ...

A Class II recall was initiated for duloxetine lots after N-nitroso-duloxetine exceeded FDA intake limits, reflecting low acute clinical risk but regulatory nonconformance. Nitrosamine issues ...

FDA’s durable expectation is that AI outputs can aid drafting, but must be reviewed and cleared by an authorized QU ...

USTR framed German payer discounts as an unfair R&D free‑ride and signaled tariffs could be avoided via negotiated price commitments, mirroring the recent UK NHS arrangement. Tariffs on US-bound ...

CAI's Jon Thompson details how digital twins cut cleanroom commissioning time by up to 30% and accelerate GMP deviation ...

Treatment pipelines for rare diseases have never been more promising. Optimizing their impact will require integrated, precision-first CDMO support systems. Rare medical conditions can do more than ...