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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The International Society for Pharmaceutical Engineering (ISPE) has proposed changes to the FDA’s draft guidance on postapproval chemistry, manufacturing and control (CMC) changes developed in collaboration with the International Council for Harmonization (ICH) for makers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
As COVID-19 drug shortages continue to plague the global supply chain, Sanofi’s arthritis drug Kevzara (sarilumab) has become the latest casualty. Read More
The FDA’s newly launched novel excipient review pilot program aims to identify possible safety issues before they can delay a drug’s application, said a senior official within the Center for Drug Evaluation and Research (CDER). Read More
More than two dozen advocacy groups have sent a letter to President Biden, urging him not to nominate Michelle McMurry-Heath, CEO of the Biotechnology Innovation Organization (BIO), for the role of FDA commissioner. Read More