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FDA issued a draft guidance Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection to help human and animal drug and biologics manufacturers prepare adequate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 …
EMA launched three major new features of PRIME, the Agency’s scheme to enhance support for the development of medicines targeting an unmet medical need. After the completion of a two-year pilot, the Agency has integrated these additional tools to support continued scientific dialogue, giving developers faster answers and better supporting preparation for the submission of a marketing …
New PRIME tools to accelerate development of medicines in the EU Read More »
The Accelerating Clinical Trials in the EU (ACT EU) initiative has published a draft guidance document outlining how clinical trials should be conducted during public health emergencies (PHEs). The guidance, now open for stakeholder consultation, The Accelerating Clinical Trials in the EU (ACT EU) initiative has published a draft guidance document outlining how clinical trials should be conducted during public health emergencies (PHEs). …
The U.S. Food and Drug Administration (FDA) has notified application holders for all drug products containing carbidopa/levodopa that the Agency is requiring the addition of a warning, and corresponding revisions, to the prescribing information to state that these medications, approved to treat symptoms of Parkinson’s disease, can cause vitamin B6 deficiency and vitamin B6 deficiency-associated …
On March 20, 2026, the Food and Drug Administration approved nivolumab (Opdivo, Bristol Myers Squibb Company) with doxorubicin, vinblastine, and dacarbazine (AVD) for adult and pediatric patients 12 years and older with previously untreated, Stage III or IV classical Hodgkin lymphoma (cHL). The FDA also granted traditional approval to nivolumab for the following indications in …
FDA approves nivolumab with chemotherapy for previously untreated Hodgkin lymphoma Read More »
