Health Canada Approves Bylvay for Cholestatic Pruritus in ALGS
OTTAWA, Canada, September 9, 2025 — Health Canada has granted approval to Bylvay™ (odevixibat) for the treatment of cholestatic...
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FDA Grants Fast Track Status to NS-229 for Rare Autoimmune Disease
PARAMUS, NJ, September 9, 2025 — The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to...
Lilly and Julianne Moore Team Up on “Brain Health Matters” Alzheimer’s Awareness Campaign
INDIANAPOLIS, Sept. 9, 2025, Eli Lilly and Company (NYSE: LLY) has launched a new global initiative, “Brain Health Matters,”...
Amneal Receives U.S. FDA Approval for Risperidone Extended-Release Injectable Suspension
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) today announced that the U.S. Food and Drug Administration (FDA) has approved its risperidone...
Anixa’s FSHR-Targeted CAR-T Shows Positive Safety, Patients Surpass Median Survival
Anixa Biosciences, Inc. (NASDAQ: ANIX), in partnership with Moffitt Cancer Center, announced the completion of dosing in the fourth...
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Jaypirca Gains Approval as First Non-Covalent BTK Inhibitor for CLL/SLL
INDIANAPOLIS, September 8, 2025 — Jaypirca (pirtobrutinib), the first and only approved non-covalent (reversible) BTK inhibitor, has demonstrated a...
FDA Issues Complete Response Letter for SL1009 in PDCD Treatment
ROSWELL, Ga., September 8, 2025 — Saol Therapeutics announced today that the U.S. Food and Drug Administration (FDA) has...
Atossa Pursues FDA Path for Low-Dose (Z)-Endoxifen in Breast Cancer Prevention
Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical-stage biopharmaceutical company, announced it has filed a request for a Type C...
Biotia Launches Advanced “Test to Treat” for Recurrent UTIs
NEW YORK, September 8, 2025 — Biotia has introduced an innovative “test to treat” pathway for patients suffering from...
Foresight Diagnostics Demonstrates Ultrasensitive MRD Detection in Early-Stage Lung Cancer at IASLC 2025
Foresight Diagnostics, a leader in ultrasensitive minimal residual disease (MRD) detection, presented new clinical performance data on its Foresight...
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