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The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended 11 new medicines for EU marketing authorizations at its July 18-21 meeting. Read More
Several cancer organizations have voiced strong support for the Biden administration’s apparent pick for National Cancer Institute (NCI) director, Monica Bertagnolli, a distinguished surgical oncologist with a long career in clinical research. Read More
The International Coalition of Medicines Regulatory Authorities (ICMRA) has published a call to bring stakeholders together in a discussion about using real-world evidence (RWE) and real-world data (RWD) in bringing new medicines to market. Read More
Sponsors of cancer drugs can apply for real-time review of their trial data if their investigational products demonstrate substantial improvements over available therapy and use straightforward study designs and endpoints that can be easily interpreted, according to a new FDA draft guidance. Read More
Biogen is writing off $275 million worth of Aduhelm (aducanumab) inventory — a formal declaration that the Alzheimer’s drug has no market value at all. Read More
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 asked questions about the Orange Book, the agency’s reference text for generic drug substitutions. Read More
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 employees after Aug. 1. Read More
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 units. Read More