Aldeyra Therapeutics, Inc. has disclosed that it has received a Complete Response Letter from the FDA regarding the New Drug Application of reproxalap.
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.
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.
In the Phase III trial for the initial treatment of recurrent/metastatic cervical cancer in all types of patients, Cadonilimab (PD-1/CTLA-4 Bispecific Antibody) has achieved the primary goal of halting disease progression.
Gracell Biotechnologies reveals FDA approval for a Phase 1/2 Clinical Trial IND application concerning FasTCAR-T GC012F, aimed at treating stubborn Systemic Lupus Erythematosus.
TC BioPharm PLC, a clinical-stage biotech company focused on allogeneic gamma-delta T cell cancer therapies, has announced FDA approval for its investigational new drug application to enter a Phase 1B trial for recurrent and refractory Acute Myeloid Leukemia.
Acadia Pharmaceuticals Inc. announces Phase 2 trial to test efficacy and safety of ACP-204 for Alzheimer's-related psychosis hallucinations and delusions.
Genmab A/S provided updates on FDA and EMA regulatory progress concerning their bispecific T-cell engaging antibody, epcoritamab, which is administered subcutaneously and under review.
Formycon AG, in collaboration with its licensing associate Klinge Biopharma GmbH, has declared the submission of the commercial application for FYB203 to the European Medicines Agency.