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...
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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...
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...
ASTHO Board Reaffirms Vaccine Support to Strengthen Public Health
Arlington, VA — September 5, 2025 — The Board of Directors of the Association of State and Territorial Health...
REGENXBIO Reports Positive 12-Month Data from RGX-121 CAMPSIITE® Trial in MPS II
EGENXBIO Inc. (Nasdaq: RGNX) announced positive 12-month pivotal data from its Phase I/II/III CAMPSIITE® trial of RGX-121 (clemidsogene lanparvovec),...
UK Approves Once-Monthly Octreotide Injection for Acromegaly Care
Lund, Sweden — August 28, 2025 — The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval...
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