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.

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.