The FDA has posted six user fee schedules for FY 2025 on the Federal Register showing increases of up to 44 percent — the highest being for biosimilars. Source: Drug…

This edition of Quick Notes includes FDA clearance for a Signum Surgical anal fistula treatment, a CE Mark for a Roche CGM system, 510(k) clearance of an augmented reality technology…

FDA recently added resources for the 2023 guidance “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations” to its Guidance Snapshot Pilot Program webpage. Source: Drug Industry Daily

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has declined to recommend approval of Eisai’s Leqembi (lecanemab) for treatment of early Alzheimer’s disease, citing concerns over the drug’s…

As the second session of the 118th Congress begins, FDAnews will track important pending legislation, that has been acted on since Dec. 31, 2023 to keep you updated on laws…

This edition of Quick Notes features announcements of Lilly’s acquisition of Morphic, a licensing agreement between SK Biopharmaceuticals and Full-Life Technologies, Agilent’s purchase of Biovectra and Cook Technologies sale of…

Brassica Pharma, a maker of sterile semi-solids, received an FDA Warning Letter for failure to test every batch for sterility as well as fabrication of test results for batches not…

Despite another attempt by Ipsen Biopharmaceuticals to regain market exclusivity for its injectable neuroendocrine tumor drug Somatuline Depot (lanreotide), an appeals court has ruled once more in favor of the…

This week, the FDA published final guidance on glass vials and stoppers, OTC monograph submissions and real-world data. Draft guidance was issued on pediatric inflammatory bowel disease and postapproval manufacturing…

FDA issued a Warning Letter to Criticare Technologies for failure to investigate complaints that its nGenuity patient vital signs monitor — which can be used during surgery — had shut…