Alnylam Pharmaceuticals begins a rolling submission of its NDA for lumasiran, an investigational RNAi therapeutic targeting glycolate oxidase for trea...
FDA says Appco and Northwind have recalled ranitidine and Mylan has recalled nizatidine due to potential NDMA contamination.
Regeneron reports positive results from the LUMINA-1 trial of its garetosmab in treating fibrodysplasia ossificans progressiva.
Health IT News reports that Google is making the FDA MyStudies open-source platform available on Google Cloud.
FDA approves a Blueprint Medicines NDA for Ayvakit (avapritinib) for treating certain adults with unresectable or metastatic gastrointestinal stromal ...
Federal Register notice: FDA proposes to withdraw approval of 249 ANDAs from multiple companies because they have repeatedly failed to file required a...
Federal Register notice: FDA submits to OMB an information collection extension for Human Tissue Intended for Transplantation 21 CFR Part 1270.
Researchers suggest ways Congress could clamp down on abuses of FDA regulatory processes that drug companies use to delay generic competition.