Mesoblast receives FDA approval for new Ryoncil potency test
Mesoblast (NASDAQ:MESO) announced that the U.S. Food and Drug Administration (FDA) has approved the use of a new potency testing method for commercial batches of Ryoncil.
Mesoblast (NASDAQ:MESO) announced that the U.S. Food and Drug Administration (FDA) has approved the use of a new potency testing method for commercial batches of Ryoncil.
Satellos Bioscience (NASDAQ:MSLE) announced that it has received U.S. Food and Drug Administration (FDA) clearance to begin studying forazapadin in patients with facioscapulohumeral muscular dystrophy (FSHD).
Ligand Pharmaceuticals (NASDAQ:LGND) announced a financing agreement with AvenCell Therapeutics that could provide up to $47 million to support development of AvenCell’s cancer treatment pipeline.
IMUNON (NASDAQ:IMNN) presented Phase 2 survival results and Phase 3 enrollment updates for IMNN-001, its investigational therapy for advanced ovarian cancer.
Ainos (NASDAQ:AIMD) announced that it has entered into a VELDONA license agreement with BioPhoenix, establishing a conditional collaboration framework with a potential value of up to $10 million.
Acadia Pharmaceuticals (NASDAQ:ACAD) announced Phase 3-enabling topline results from the Phase 2 portion of its ongoing RADIANT clinical trial program evaluating remlifanserin for hallucinations and delusions associated with Alzheimer’s disease psychosis (ADP).
Merck (NYSE:MRK) announced topline results from the pivotal Phase 2b/3 BRUNELLO trial evaluating remigromig (MK-3000, formerly EYE103) in adults with diabetic macular edema (DME).
Eli Lilly (NYSE:LLY) received U.S. Food and Drug Administration approval on September 24, 2026, for Onswik, a once-weekly basal insulin treatment for adults with type 2 diabetes.
Biodesix (NASDAQ:BDSX) announced progress on two molecular residual disease (MRD) testing programs designed to detect circulating tumor DNA (ctDNA) in blood samples following cancer treatment.
MediciNova (NASDAQ:MNOV) announced the completion of the last patient’s final visit in the double-blind portion of its Phase 2b/3 COMBAT-ALS trial evaluating MN-166 (ibudilast) for amyotrophic lateral sclerosis (ALS).
aTyr Pharma (NASDAQ:ATYR) announced FDA alignment on the planned Phase 3 study protocol for efzofitimod in patients with pulmonary sarcoidosis on September 24, 2026.
Kyverna Therapeutics (NASDAQ:KYTX) reported updated clinical data for its investigational CAR-T therapy miv-cel (mivocabtagene autoleucel) in stiff person syndrome (SPS) and generalized myasthenia gravis (gMG).
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