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.

FAK, or Focal Adhesion Kinase, is a crucial protein involved in various cellular processes within the human body.

Priority review is intended to expedite the FDA's review of new drugs and vaccines that have the potential to offer significant improvements over available therapies for serious conditions.

On 15 Apr 2023, the updated PFS & OS from the interim analysis (data cutoff Oct 14, 2021) of the study (NCT03910127) was reported at the AACR Congress, illustrating its potential clinical benefits and setting the stage for further exploration.

FDA has implemented several policies and programs to accelerate the process of drug marketing

In the CAR-T field, we can perform comprehensive data retrieval of CAR-T in two major parts: antibody search and CAR expression cassette design.