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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 …

FDA Workshop Will Focus on Development of Antihypertensive Therapies for Use in Pediatric Patients Read More »

On June 12, 2026, the Food and Drug Administration approved belzutifan (Welireg, Merck & Co., Inc.) in combination with pembrolizumab (Keytruda, Merck & Co., Inc.) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck & Co., Inc.) for the adjuvant treatment of adults with renal cell carcinoma with a clear cell component (ccRCC) at intermediate-high or …

FDA approves belzutifan with pembrolizumab for adjuvant treatment of renal cell carcinoma Read More »

On June 12, 2026, the Food and Drug Administration approved capivasertib (Truqap, AstraZeneca) in combination with abiraterone and prednisone for adults with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer (previously referred to as metastatic hormone-sensitive prostate cancer) that is PTEN-deficient as detected by an FDA-authorized test. The FDA also approved the VENTANA PTEN …

FDA approves capivasertib with abiraterone and prednisone for PTEN-deficient androgen pathway modulation-naïve or -sensitive prostate cancer Read More »

FDA reopened the comment period for an additional 30 days for the docket to solicit public comment on the multiple guidances for industry on scale-up and postapproval changes (SUPAC) for specific dosage forms

The Food and Drug Administration (FDA) has approved changes to the Drugs Facts Label of the over-the-counter (OTC) weight loss drug, alli (orlistat) 60 mg capsules, to warn of risks of acute kidney injury, which is a rare side effect of the medication. The labeling now advises consumers to ask a health care provider before using alli …

FDA Approves Labeling Changes for Over-the-Counter (OTC) Weight Loss Drug alli (Orlistat) to Warn of Risk of Kidney Stones and Kidney Injury Read More »

This virtual training is designed to help staff at academic medical centers meet the federal requirements for registering clinical studies and reporting results on ClinicalTrials.gov. Specialists from the U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH) will address frequently asked questions regarding regulatory obligations and the ClinicalTrials.gov Protocol Registration and Results System (PRS).

Today, the U.S. Food and Drug Administration is extending the comment period by 30 days for the Request for Information on Drug Repurposing for Unmet Medical Needs. On May 12, 2026, the FDA issued a Request for Information to solicit input and comments on FDA’s efforts with respect to drug repurposing to address unmet medical needs.

EMA’s Emergency Task Force (ETF) is engaging with the African Medicines Agency (AMA) and its national regulatory authorities (NRAs), leveraging expertise from the WHO-AFRO African Vaccines Regulatory Forum (AVAREF), to discuss possible clinical trial designs and medical countermeasures to be investigated in the ongoing Ebola outbreak in the Democratic Republic of the Congo (DRC) and Uganda, caused …

EMA, AMA and African regulatory authorities join forces on Ebola outbreak response Read More »

On May 13, 2026, the FDA Center for Drug Evaluation and Research, in partnership with the CDER Quantitative Medicine Center of Excellence, announced a request for information regarding an initiative to advance biomarker validation through data compilation from multiple sources. Specifically, a pilot project was launched that focuses on aggregating data for biomarkers of drug-induced …

FDA Announces Request for Information Regarding Biomarkers of Drug-Induced Kidney Injury Read More »