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Roche has run into another roadblock for its investigational dual-agent chemotherapy regimen targeting PD-L1-high locally advanced or metastatic nonsmall-cell lung cancer (NSCLC). Read More
The FDA’s Center for Drug Evaluation and Research (CDER) is launching a new initiative to speed and increase the development of treatments for rare diseases. Read More
The troubled manufacturing plant Emergent BioSolutions concealed proof of quality problems at its Baltimore, Md., location just a month and a half before it told the FDA that 15 million COVID-19 vaccine doses manufactured there had been contaminated. Read More
Human radiolabeled mass balance studies are the most direct way of gathering quantitative data on a drug’s absorption, distribution, metabolism and excretion (ADME) in the human body, according to draft guidance the FDA issued last week. Read More
A pooled data analysis of phase 2b and 3 data is strengthening claims that a single dose of nirsevimab can protect infants from respiratory syncytial virus (RSV) infections. Read More
The pilot program will analyze data from pharmacy suppliers and consider such supply chain issues as available production capacity, flexibility and geopolitical risks. Read More
The FDA hit Carlsbad, Calif.-based SAFC Carlsbad — a MilliporeSigma property — with a seven-observation Form 483 following a December 2021 inspection, citing inadequate handling of biohazardous materials and other quality lapses. Read More
On Monday, a two-week trial got under way to determine the contributions that pharmacy chains CVS Health Corp, Walgreens Boots Alliance and Walmart made to the opioid crisis in two hard-hit Ohio counties. Read More