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Any changes made in a unit operation of continuous manufacturing may have a direct and often immediate impact on downstream and upstream operations, the agency said. Read More
The European Medicines Agency’s (EMA) expert panel on human medicines has recommended approval for Gilead Sciences’ novel therapy for an aggressive form of breast cancer and for five other drugs. Read More
A federal judge has denied a motion from the Department of Justice (DOJ), seeking to stop the disbursement of $10 billion of Purdue Pharma opioids settlement money while the appeals process is ongoing. Read More
Molnupiravir, the controversial COVID-19 oral antiviral made by Merck and subsidiary Ridgeback Therapeutics, will have its day in committee, the FDA has announced. Read More
A day after its unanimous vote in favor of Moderna’s COVID-19 booster shot, a panel of vaccine experts that advises the FDA also voted unanimously to grant Johnson & Johnson’s (J&J) COVID-19 booster shot Emergency Use Authorization (EUA). Read More
An additional dose of the same vaccine as the primary series boosted antibody levels four- to 20-fold, while mixing and matching primary vaccines and booster doses boosted antibody levels six- to 76-fold. Read More
Former FDA Commissioner Robert Califf is likely to be the Biden administration’s nominee to replace acting commissioner Janet Woodcock and take up the role of the agency’s permanent head once again. Read More
The International Society for Pharmaceutical Engineering (ISPE) has proposed changes to the FDA’s draft guidance on postapproval chemistry, manufacturing and control (CMC) changes developed in collaboration with the International Council for Harmonization (ICH) for makers of drugs and drug-device combination products. Read More
They contend that serving as head of a large industry trade association is disqualifying since McMurry-Health has represented the interests of hundreds of FDA-regulated companies. Read More