Epix will resubmit imaging NDA
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Epix Pharmaceuticals will resubmit an NDA for its novel vascular imaging agent Vasovist (gadofosveset trisodium) in mid-2008. After issuing two "approvable" letters for the agent, FDA proposed a protocol design and statistical analysis plan that could help the drug gain approval. The Lexington, Mass.-based firm said they received an action letter confirming the agreement Feb. 2...
You may also be interested in...
Roche Gets Adjuvant ALK+ Lung Cancer To Itself With Alecensa Approval
The US FDA cleared Roche’s supplemental approval request for ALK inhibitor Alecensa in ALK-positive non-small cell lung cancer following tumor resection.
MoCRA’s Adulteration Ambiguity And FDA’s New Cosmetic Recall Authority: Attorney Weighs In
The US FDA should use guidance or rulemaking to clarify MoCRA provisions related to adulteration, Amin Wasserman Gurnani attorney Angela Diesch suggested at the Independent Beauty Association’s Cosmetics Convergence Spring Symposium. Attendees also sought her take on whether the agency’s new recall authority is likely to spell an increase in cosmetic product recalls.
Medtronic Launches Remote Live-Stream Surgery, New AI Capabilities
Medtronic will launch a new feature that allows for live streaming of surgical procedures in more than 20 countries and the addition of 14 AI-driven algorithms to enhance surgical workflow.