On June 22, the U.S. Food and Drug Administration (FDA) published the draft guidance entitled “Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) Trials.” FDA seeks feedback on this guidance document.
On June 24, 2026, the Food and Drug Administration approved sacituzumab govitecan-hziy (Trodelvy, Gilead Sciences, Inc.) for two indications in adults with triple-negative breast cancer (TNBC). The first indication, supported by ASCENT-03, is for sacituzumab govitecan-hziy as a single agent for the first-line treatment of adults with unresectable locally advanced or metastatic TNBC who are …
On June 24, 2026, the Food and Drug Administration approved palbociclib (Ibrance, Pfizer Inc.) in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adults with HR-positive, HER2-positive locally advanced or metastatic breast cancer following induction treatment.
The U.S. Food and Drug AdThe U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has released the 2025 Drug Trials Snapshots (DTS) Summary Report.ministration’s (FDA) Center for Drug Evaluation and Research (CDER) has released the 2025 Drug Trials Snapshots (DTS) Summary Report.
The U.S. Food and Drug Administration (FDA) has approved Tryngolza (olezarsen), used with diet, to reduce triglycerides and the risk of acute pancreatitis in adults with severe hypertriglyceridemia.
Today, the U.S. Food and Drug Administration (FDA) announced the availability of a technical specifications document Submitting Clinical Trial Datasets to Evaluate the Impact of Immunogenicity on the Pharmacokinetics of a Drug. The specifications detailed in this guidance were built to support the data standards and processes described in the technical specifications document Study Data Technical Conformance Guide (March …
The U.S. Food and Drug Administration (FDA) has approved Utebzi (tebipenem pivoxil) tablets for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, caused by several susceptible microorganisms in adults who have limited or no alternative oral treatment options.
U.S. Food and Drug Administration requested labeling updates for all generic drugs referencing Accutane (isotretinoin) capsules as their reference listed drug (RLD). These updates are necessary because new scientific evidence exists that is not reflected in current labeling, and the approved labeling does not follow the current format that better serves healthcare providers.
This FDA public workshop, hosted with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), will bring together key stakeholders, including clinicians, academicians, regulators, industry, and patients/caregivers, to discuss the similarities and differences in disease pathophysiology and drug response across age groups, determine the extent to which efficacy can be extrapolated …
