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. Source: Drug…

It’s looking more and more likely that Congress will miss its deadline to pass a user-fee reauthorization bill — potentially forcing the agency into sending out furlough notices to its…

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. Source: Drug Industry Daily

In a pair of final guidances published Friday, the FDA outlined acceptable reasons for requesting an extension for responding to a Complete Response Letter (CRL) and provided answers to frequently…

Countries participating in this year’s Pangea XV, an international illicit drug crackdown, made more than 7,800 seizures of illicit and misbranded medicines worth $11 million and totaling 3 million individual…

The European Medicines Agency is calling for public comment on the International Council for Harmonization (ICH) new draft guidance on conducting drug interaction studies. Source: Drug Industry Daily

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). Source: Drug Industry Daily

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…

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…

It’s getting crowded on the cell therapy bandwagon — and it won’t be able to hold many more passengers, according to a market analysis by GlobalData. Source: Drug Industry Daily