Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Pfizers Vyndamax (tafamidis).
FDA approves an Astellas Pharma BLA for Vyloy (zolbetuximab-clzb) in combination with fluoropyrimidine- and platinum-containing chemotherapy for the f...
GE Healthcare recalls its Giraffe OmniBed neo-natal incubator after receiving reports about the screw that secures the door becoming loose.
FDA issues a partial clinical hold on a BioNTech and OncoC4, Phase 3 trial that is assessing gotistobart in non-small cell lung cancer.
Federal Register notice: FDA makes available a draft guidance entitled Postoperative Nausea and Vomiting: Developing Drugs for Prevention.
Federal Register notice: FDA makes available a final guidance entitled Core Patient-Reported Outcomes in Cancer Clinical Trials.
Federal Register notice: FDA makes available a final guidance entitled Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neon...
FDA releases a guidance entitled Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA. `
