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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The Accelerating Clinical Trials in the EU (ACT EU) initiative has published a draft guidance document outlining how clinical trials should be conducted during public health emergencies (PHEs).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now open for stakeholder consultation, The Accelerating Clinical Trials in the EU (ACT EU) initiative has published a draft guidance document outlining how clinical trials should be conducted during public health emergencies (PHEs). …

New guidance on the conduct of clinical trials during public health emergencies in the EU Read More »

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 …

FDA Is Requiring Warning about Vitamin B6 Deficiency and Associated Seizures for Drug Products Containing Carbidopa/Levodopa Read More »

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 »

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled “General Considerations for the Use of New Approach Methodologies in Drug Development.” The purpose of this draft guidance is to provide drug developers with a validation framework and general recommendations for using new approach methodologies …

FDA posts draft guidance on “General Considerations for the Use of New Approach Methodologies in Drug Development” Read More »

The Food and Drug Administration (FDA) published the final guidance for industry entitled “Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs.” This guidance finalizes the draft guidance for industry of the same title issued on October 21, 2022.

The U.S. Food and Drug Administration (FDA) recently published the guidance for industry, QTc Information in Human Prescription Drug and Biological Product Labeling (December 2025). This guidance provides recommendations to help ensure clinically relevant information on heart rate-corrected QT (QTc) interval prolongation (certain changes in the electrical activity of the heart) is included in the U.S. Prescribing Information of non-antiarrhythmic prescription …

FDA Publishes Guidance with Recommendations on Including QTc Information in Drug Labeling Read More »