Regulatory News & FDA Approvals
The latest regulatory news and FDA approvals.
FDA Approves Entrogen's RAS Mutation Detection Kit as CDx for Vectibix
The test, intended for use with Amgen's Vectibix, detects KRAS and NRAS exon 2, 3, and 4 mutations in colorectal cancer patients.
Takeda to Withdraw Exkivity Accelerated Approval in EGFR-Mutant NSCLC in US, Globally
The firm said the Phase III confirmatory trial of Exkivity in first-line EGFR exon 20 insertion-positive advanced NSCLC did not meet its primary endpoint.
ProciseDx Gets US Marketing Clearance for Infliximab, Adalimumab POC Monitoring Tests
The firm plans this year to launch in the US its tests used to measure drug levels in inflammatory bowel disease patients and guide treatment.
Translational Software Shutting Down PGx Decision Support Services After FDA Regulatory Defeat
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The firm was pursing 510(k) clearance for software that provides treatment recommendations based on PGx variants detected by lab customers, but the FDA issued a negative decision.
Rocket Pharmaceuticals' Leukocyte Adhesion Deficiency-I Gene Therapy Under FDA Priority Review
The drugmaker submitted data from a Phase I/II study in which all nine LAD-I patients who received the one-time RP-L201 infusion were alive after one year.