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The U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Translational Sciences (OTS), Office of Clinical Pharmacology (OCP) announced the release of the 2025 OCP Annual Report. OCP is a dynamic, purpose-driven organization dedicated to promoting and protecting global public health through the application of clinical pharmacology and translational …

FDA’s Office of Clinical Pharmacology Announces Release of Its 2025 Annual Report Read More »

The U.S. Food and Drug Administration approved the first generics of FARXIGA (dapagliflozin) tablets to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors, and as an adjunct to diet and exercise to improve glycemic control in adults with …

FDA Approves First Generic Dapagliflozin Tablets Read More »

The Food and Drug Administration is announcing a public workshop, “Optimizing Pregnancy Registries,” to be held May 7-8, 2026 at the FDA White Oak Campus and online. The purpose of the public workshop is to discuss challenges in designing and implementing pregnancy registries and to consider innovative approaches to improve the design and conduct of …

FDA to Host Public Workshop on Optimizing Pregnancy Registries Read More »

FDA recently published the guidance snapshot and podcast for the draft guidance Use of Bayesian Methodology in Clinical Trials of Drugs and Biologics.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 »