Tracy Beth Høeg said she was fired; Katherine Szarama departs as acting CBER director but remains at FDA, signaling rapid ...

Mihaela Simianu and Austin Caudle join the show to discuss how digital container twins can improve pharma manufacturing, validation, and risk reduction.

Understand how Piramal leads the CDMO market in delivering well-constructed and well-executed integrated services. Learn why programs need to consider both drug substance and drug product from the ...

Upstream titers of 3–5 g/L, and up to 10–13 g/L, are outpacing downstream capacity, creating chromatography, filtration, and UF/DF throughput bottlenecks that elevate cost and delay timelines. Complex ...

There is a significant reliance on manual workarounds. When a drug becomes unavailable, pharmacy teams may need to compound ...

Building resilient, adaptable operations capable of evolving alongside the rapid transformation of the biologics industry is key for downstream processing.

Valerie Bandy, Tecsys, discusses how manufacturers are adopting data-driven supply chain strategies to reduce drug shortages, ...

Regionalized early development affects clinical supply, analytical transfer, comparability strategies, and regulatory ...

FDA leadership churn and reported political interference eroded internal cohesion, contributing to resignations of senior career officials and a climate of dysfunction impacting scientific review ...

European biopharma companies are looking beyond GLP-1s. Obesity is a major public health threat and is associated with an increased risk of obesity-related complications and mortality. It has proved a ...

Benralizumab gained approval for adult and pediatric hypereosinophilic syndrome with a 65% flare-risk reduction, underscoring lifecycle strategies that impose distinct dosing, formulation, and ...

Reports indicate White House approval to remove Marty Makary, reflecting internal discomfort with political fallout from provocative regulatory shifts and intensifying congressional and ...