The American Journal of Managed Care

FDA Will Require Only 1 Study to Approve New Drugs, Speeding Up Process

A commentary by FDA officials Vinay Prasad, MD, MPH, and Martin Makary, MD, MPH, details the new system for drug approvals in the US. FDA Commissioner Martin Makary, MD, MPH, and his top deputy Vinay ...
Cure Today

FDA to Review New Drug Combo for Previously Treated Metastatic Colorectal Cancer

Zanzalintinib plus Tecentriq showed improved survival in metastatic colorectal cancer patients compared to Stivarga in the STELLAR-303 trial. The FDA accepted the new drug application for this ...
Seeking Alpha

FDA Issues Complete Response Letter for Biohaven's VYGLXIA (troriluzole) New Drug Application for Spinocerebellar Ataxia

The troriluzole clinical development program encompassed the first industry clinical trials to generate data showing therapeutic potential in patients with spinocerebellar ataxia (SCA), a rare genetic ...
Seeking Alpha

Disc Medicine Announces Submission of New Drug Application (NDA) to US FDA for Accelerated Approval of Bitopertin for Patients with Erythropoietic Protoporphyria (EPP)

Disc is seeking accelerated approval and priority review of its NDA submission FDA decision to accept and file the NDA for review occurs within 60 days of submission WATERTOWN, Mass., Sept. 30, 2025 ...
Regulatory Affairs Professionals Society

Asia-Pacific Roundup: Hong Kong starts phased shift to independent assessment of new drug submissions

Hong Kong’s Department of Health (DH) has begun a phased transition to the independent assessment of primary data on new ...