In the face of inveterate manufacturer foot-dragging and a dearth of certified review bodies, the European Commission (EC) is once again proposing to extend the deadline for companies to comply…
Less than two months after its announced investigation of secondary T-cell cancers in patients who received chimeric antigen receptor (CAR)-T cell immunotherapy cancer treatments, the FDA is mandating label updates…
The European Medicines Agency (EMA) has released a major revision of its user guide for micro, small, and medium-sized enterprises (SME) in the pharmaceutical sector, including updates to reflect new…
Sanofi and Inhibrx, a clinical-stage biopharmaceutical company focused on developing a pipeline of novel biologic therapeutic candidates, today announced a $2 billion agreement for Sanofi to acquire Inhibrx. Source: Drug…
The FDA’s newest draft guidance addresses premarket submission requirements for Class II and III implantable orthopedic devices coated with metals, calcium phosphate, or a combination of those materials. Source: Drug…
This edition of Quick Notes looks at the FDA approving devices and systems that detect and/or offer treatment for potential skin cancer, Alzheimer’s, lung fibrosis and diabetic neuropathy. Source: Drug…
A boxed warning has been added to the labeling for Prolia (denosumab) based on FDA review of information on the risk of severe hypocalcemia, very low blood calcium levels, in…
As the second session of the 118th Congress begins, FDAnews will track important pending legislation, that has been acted on since Oct. 1, 2023 to keep you updated on laws…
CDRH set a new record last year, says its latest annual report, granting marketing authorization to 124 novel devices, excluding emergency use authorizations (EUAs), the highest in the more than…
The FDA has warned Novartis that its direct to consumer TV ad for its breast cancer drug Kisqali (ribociclib) makes false or misleading representations about the drug’s efficacy, sending the…