In a functioning system, the kind of placebo-controlled vaccine trials that Secretary Kennedy is calling for would never get past an IRB, much less progress to an IND application. Vaccines are being ...

Global pharma major Lupin Limited (Lupin) announced that it has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application for prucalopride ...

Revuforj is designed to treat patients with relapsed or refractory mutant NPM1 acute myeloid leukemia. The application has been assigned a real-time oncology review, which allows for a more efficient ...

In a Phase I/II clinical trial, TKI-pretreated NSCLC patients given zidesamtinib had an overall response rate of 44 percent.

In announcing his new Commissioner's National Priority Voucher (CNPV) program, FDA Commissioner Marty Makary, MD, MPH, ...

The initiative, referred to as the Commissioner’s National Priority Voucher program, allows drug developers to participate in a novel FDA priority program. The program significantly shortens the FDA ...