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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 …

FDA Announces the Availability of the Technical Specifications Document “Submitting Clinical Trial Datasets to Evaluate the Impact of Immunogenicity on the Pharmacokinetics of a Drug” Read More »

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 …

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 »