Delcath subgroup data links survival to tumor burden and LDH in uveal melanoma
New Phase 3 subgroup data suggest Delcath’s HEPZATO KIT improves survival in patients with lower tumor burden or LDH. Learn what this means for mUM treatment.
Could Vanda’s success with NEREUS revive interest in neurokinin-1 pathways?
NEREUS becomes first FDA-approved motion sickness drug in 40 years. Find out how this approval could reshape antiemetic strategies across industries.
Is BRCA the new EGFR? Why germline mutations are reshaping prostate cancer treatment strategies
Rubraca’s FDA approval before chemo in BRCA-mutated prostate cancer could reshape precision treatment. See what this changes for mCRPC strategy.
Tolmar secures FDA nod for pre-chemo Rubraca use in BRCA-mutated prostate cancer
Tolmar Inc. has received expanded approval from the U.S. Food and Drug Administration for Rubraca (rucaparib), enabling its use before chemotherapy in patients with metastatic castration-resistant prostate cancer who carry BRCA mutations. The decision was based on results from the TRITON3 Phase 3 trial, which showed Rubraca to be the first and only PARP inhibitor […]
GSK’s Exdensur wins FDA nod for severe asthma: Can twice-yearly dosing reset the biologics playbook?
GSK’s Exdensur has been approved by the FDA as the first biannual biologic for severe asthma. Find out what this means for patients, payers, and rivals.
Bioretec secures FDA Breakthrough status for RemeOs DrillPin, sharpening focus on pediatric fracture repair
Bioretec Ltd, the Finland-based medical device developer specializing in fully biodegradable orthopedic implants, has received Breakthrough Device Designation from the U.S. Food and Drug Administration for its RemeOs DrillPin. The designation applies to the use of the biodegradable magnesium-alloy device in pediatric and adult bone fixation procedures, including epimetaphyseal fractures in children over two years […]
Waskyra approved for Wiskott-Aldrich syndrome: What it means for stem cell alternatives
Fondazione Telethon has received regulatory approval from the United States Food and Drug Administration for Waskyra (etuvetidigene autotemcel), an ex vivo gene therapy designed to treat Wiskott-Aldrich syndrome, a rare X-linked primary immunodeficiency. This approval makes Waskyra the first gene therapy for this condition cleared for use in the United States and solidifies Fondazione Telethon’s […]
How Innoviva’s NUZOLVENCE could reshape STI care and resistance strategy
Innoviva Specialty Therapeutics has received approval from the U.S. Food and Drug Administration for NUZOLVENCE (zoliflodacin), a first-in-class, single-dose oral antibiotic for the treatment of uncomplicated urogenital gonorrhea in adults and adolescents. This approval, based on the largest-ever Phase 3 clinical trial for a new treatment against Neisseria gonorrhoeae, marks the first new oral gonorrhea […]
Acadia expands DAYBUE delivery formats for Rett syndrome with powder-based STIX
Acadia Pharmaceuticals has announced U.S. Food and Drug Administration approval for DAYBUE STIX (trofinetide) for oral solution, a new powder-based formulation of its existing drug DAYBUE used in the treatment of Rett syndrome. The approval covers use in adult and pediatric patients two years and older and is based on bioequivalence data, not new clinical […]
Can B-cell depletion change how we treat generalized myasthenia gravis?
Amgen has received approval from the United States Food and Drug Administration for Uplizna (inebilizumab-cdon) to treat adults with generalized myasthenia gravis who are anti-acetylcholine receptor or anti-muscle specific tyrosine kinase antibody positive. The greenlight makes Uplizna the first and only CD19-targeted B cell therapy approved for this patient population, introducing a twice-yearly dosing regimen […]