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...
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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...
Precision Robotic CERTA Access System Records First U.S. Clinical Outcomes
Fort Lauderdale, FL – September 4, 2025 – The first U.S. clinical cases using the CERTA™ Access System, a...
Senhwa’s CX-5461 Gains FDA IND Clearance and NCI Support to Advance in MYC-Driven Lymphoma
Senhwa Biosciences, Inc. (TPEx: 6492), a clinical-stage biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has...
IDEAYA Biosciences Enrolls First Patient in Phase 1/2 Combination Trial of IDE397 and Trodelvy® in MTAP-Deletion NSCLC
IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision medicine oncology company, announced the enrollment of the first patient in its...
Covariate Adjustment Sharply Improves Clinical Trial Precision
MONT-SAINT-GUIBERT, Belgium, September 4, 2025 — A recent peer-reviewed study in The Journal of Pain demonstrates that a streamlined...
NeuroSense Therapeutics Announces $500,000 Private Placement at Premium to Market Price
NeuroSense Therapeutics Ltd. (NASDAQ: NRSN), a late-clinical stage biotechnology company developing therapies for neurodegenerative diseases, has entered into a...
FDA Approves First RNA Therapy for Hereditary Angioedema Prophylaxis
CARLSBAD, Calif., August 21, 2025 — The U.S. Food and Drug Administration (FDA) has approved DAWNZERA™ (donidalorsen), the first...
FDA Grants Breakthrough Therapy Designation to HERNEXEOS® for First-Line Treatment of HER2-Mutant Advanced NSCLC
Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for HERNEXEOS®...
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