CBER continues to monitor the safety and stability of biological products that have been approved.

Based on previous studies, biomarker analysis from Phase 1/2 study of tusamitamab ravtansine (SAR408701) in patients with advanced non-small cell lung cancer (NSCLC) was reported at the AACR Congress.

Due to HDAC’s fundamental role in gene expression and its different effects on histones and non-histones, HDAC has become an ideal target for the treatment of various malignant tumors. HDAC inhibitors are considered one of the most promising anti-cancer drugs.

TOLREMO Initiates Phase 1 Study by Administering TT125-802 to Initial Participant, an Innovative Compound Targeting Transcriptional Resistance in Cancer Treatment.

Death is not an AE because it is a final outcome of the patient's condition, rather than an adverse event itself.

Recent results presented at the AACR Congress show the benefit of durvalumab with chemotherapy, then as an adjuvant, in resectable NSCLC patients, confirming immunotherapy's effectiveness in both neoadjuvant and adjuvant stages.

The European medicines regulatory system is based on a network of around 50 regulatory authorities from the 30 EEA countries (27 EU Member States plus Iceland, Liechtenstein and Norway), the European Commission and EMA.

Aldeyra Therapeutics, Inc. has disclosed that it has received a Complete Response Letter from the FDA regarding the New Drug Application of reproxalap.

Dose expansion trials are clinical trials that evaluate the safety, pharmacokinetics, pharmacodynamics, and clinical activity of a new drug or treatment in a larger group of patients than in the initial dose escalation trial.

HIV-1 protease inhibitors are a type of medication used to treat HIV by blocking the virus from entering certain cells in the body and making copies of itself.

CBER, or the Center for Biologics Evaluation and Research, is one Center within the Food and Drug Administration, an Agency within the United States Government's Department of Health and Human Services (HHS).

NMRA-266, a molecule with selective affinity for enhancing the activity of the M4 muscarinic receptor, is being advanced by Neumora as a potential therapeutic option for the management of schizophrenia as well as various additional mental health conditions.