Edwards Lifesciences’ SAPIEN M3 FDA approval marks a turning point for transseptal mitral valve therapy
Edwards Lifesciences’ SAPIEN M3 becomes the first FDA-approved transseptal mitral valve replacement system. Explore how it reshapes TMVR in 2026.
Medical Devices & Diagnostics
Pharma & Biotech
Omeros secures FDA approval for YARTEMLEA, the first therapy for transplant-associated TA-TMA
FDA approves YARTEMLEA for TA-TMA. Find out how Omeros’ new drug could change transplant care for children and adults alike.
Pharma & Biotech
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.
Pharma & Biotech
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.
Pharma & Biotech
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.
Pharma & Biotech
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
Pharma & Biotech
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.
Medical Devices & Diagnostics
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
Pharma & Biotech
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
Pharma & Biotech
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