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 ...

World leaders are dismantling global health programs and cutting back foreign aid. Will an extraordinary new medicine be able ...

Targeted Oncology connects oncology professionals with updates on immunotherapy, biomarkers, cancer pathways, and targeted ...

FDA approval of VYKAT XR for hyperphagia in Prader-Willi Syndrome marks a major milestone for Soleno Therapeutics.

Research discoveries leading to the development of new pharmaceutical compounds are notoriously difficult to translate into clinical practice.1 Drug repurposing provides a strategy to identify ...

The Supreme Court ruled on Friday that a challenge by retailers to the Food and Drug Administration’s denial of an ...