Regulatory News & FDA Approvals
The latest regulatory news and FDA approvals.
In Brief This Week:Â Cleveland Diagnostics, Genprex, Viome
News items for the week of May 3, 2021.Â
UK's MHRA Grants Early Access to AstraZeneca's Tagrisso as Adjuvant NSCLC Treatment
This is MHRA's first authorization under Project Orbis, an international regulatory collaboration the UK body joined in January to speed access to drugs.
FDA Approves Keytruda-Herceptin Combination for HER2-Positive Gastric, Gastroesophageal Cancer
The agency granted accelerated approval to Merck's pembrolizumab plus Herceptin and chemotherapy for patients with advanced, HER2-positive gastric cancer.
FDA Accepts IND for Clarity Pharmaceuticals' Prostate Cancer Radiopharmaceutical
Clarity will begin a Phase I/II trial of its diagnostic and therapeutic product pairing to treat PSMA-positive, metastatic prostate cancer.
FDA Expert Panel Votes Against Keytruda Accelerated Approval for PD-L1-Positive Gastric Cancer
The ODAC voted to remove the accelerated approval due to the absence of demonstrated overall survival benefit in confirmatory clinical trials.
Mar 30, 2021