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The FDA announced Friday that remote regulatory assessments (RRA) have proven to be a valuable tool and the agency will continue to use them beyond the COVID-19 pandemic. Read More
The FDA issued a proposed rule on Friday that would require drugmakers to use a standardized 12-digit National Drug Code (NDC) format with three distinct segments. Read More
The European Medicines Agency is calling for public comment on the International Council for Harmonization (ICH) new draft guidance on conducting drug interaction studies. Read More
Novartis no longer plans to submit PD-1 checkpoint inhibitor tislelizumab for approval in the U.S. as a monotherapy for nonsmall-cell lung cancer (NSCLC). Read More
In a worrying sign for several drug candidates, Roche said it has halted five phase 1 and 2 trials evaluating therapies for major diseases including cancers, asthma and a metabolic disorder. Read More
Amneal Pharmaceuticals subsidiary Impax Laboratories has agreed to pay $145 million to settle allegations it partnered with Endo International to illegally delay the launch of a generic of Endo’s opioid painkiller Opana ER (oxymorphone). Read More
“If you have been waiting for a COVID-19 vaccine built on a different technology than those previously available, now is the time to join the millions of Americans who have been vaccinated,” said CDC Director Rochelle Walensky. Read More