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FDA recently published the guidance snapshot and podcast for the draft guidance Use of Bayesian Methodology in Clinical Trials of Drugs and Biologics. FDA’s Guidance Snapshot Pilot Program aims to increase the general public’s awareness of and engagement with FDA guidance documents—and support the efficient application of recommendations. The snapshot highlights key points in the guidance document and is not a substitute for the …

Available Now: Guidance Snapshot for Guidance Use of Bayesian Methodology in Clinical Trials of Drugs and Biologics Read More »

EMA has recommended granting a marketing authorisation in the European Union (EU) for Imdylltra (tarlatamab) as monotherapy to treat adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease relapsed during or after an initial treatment with platinum-based chemotherapy.

EMA has issued recommendations for the influenza virus strains that vaccine manufacturers should include in vaccines for the prevention of seasonal influenza from autumn 2026.

EMA’s human medicines committee (CHMP) has issued a draft qualification opinion for a new methodology in preclinical research, which can reduce the overall number of animals (rats) used in specific dose-range finding studies. This method replaces standard (concurrent) animal control groups with virtual control groups. By qualifying this new approach methodology (NAM), the CHMP can accept evidence generated …

EMA consults on virtual control groups to help reduce animal use in medicines development Read More »

FDA is alerting patients and health care professionals about serious postmarketing cases, including fatal cases, of drug-induced liver injury (DILI) associated with Tavneos (avacopan). Some cases involved vanishing bile duct syndrome (VBDS), which is characterized by progressive destruction and disappearance of the bile ducts in the liver. This condition can slow or stop the flow …

FDA Identifies Cases of Serious Liver Injury in Patients Taking Tavneos (avacopan) for Severe Active Anti-neutrophil Cytoplasmic Autoantibody (ANCA)-associated Vasculitis Read More »

On March 25, 2026, FDA’s Center for Drug Evaluation and Research published its fiscal year 2025 Generic Drug User Fee Amendments (GDUFA) Science and Research Report at https://www.fda.gov/drugs/generic-drugs/fy-2025-gdufa-science-and-research-report.

On March 25, 2026, the Food and Drug Administration approved relacorilant (Lifyorli, Corcept Therapeutics Inc.), a glucocorticoid receptor antagonist, in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab.

FDA issued a draft guidance Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection to help human and animal drug and biologics manufacturers prepare adequate responses to the agency when the manufacturer receives a form 483 at the end of an inspection. The guidance provides recommendations on how to submit a clear and well-organized …

FDA Issues Guidance on Form 483 Responses Read More »