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.

The subjects should be informed about any changes in the protocol and asked for their consent before proceeding with the new procedures.

On 14 Apr 2023, the first-in-class first-in-human phase 1 trial and translational study of the mono (ADP-ribose) polymerase-7 (PARP7) inhibitor RBN-2397 was reported at the AACR Congress.

The advantages of eCRF over CRF include:Digital format,Security,Transportation,Ease of use,Flexibility.

SpringWorks Therapeutics, Inc., a biopharma company focused on severe rare diseases and cancer, has announced FDA approval for OGSIVEO™ (nirogacestat), an oral gamma secretase inhibitor, to treat progressive desmoid tumors in adults requiring systemic therapy.

The FDA's priority review process is designed to expedite the development and review of new drugs.

On 14 Apr 2023, the first-in-human phase 1 trial of IO-108 as monotherapy and in combination with pembrolizumab in adult patients with advanced relapsed or refractory solid tumors was reported at the AACR Congress.

HIV-1 integrase inhibitors block the catalytic activity of integrase to prevent the integration of viral DNA into the human genome, thereby preventing HIV virus replication.

A promoter, in genetics, refers to a region of DNA where transcription of a gene commences.

Drug infusion rates are often controlled in clinical trial protocols to ensure that the study participants receive a consistent and safe dose of the drug being tested.

A probe, in the scientific context of genomics and molecular biology, refers to a small, single-stranded molecule of DNA or RNA designed for hybridising with a specific section of the genome.