Establishment Labs seeks FDA nod for Motiva breast reconstruction implants

Motiva, SmoothSilk, Round and Ergonomix implants represent the latest in plastic surgery innovation

Kokilaben Dhirubhai Ambani Hospital makes history with India’s first intercontinental remote robotic surgeries

The Toumai platform, currently the only robotic system with US FDA Study Approval for telesurgery, enabled real-time surgical control with no compromise to patient safety

INOVIO’s DNA therapy for rare throat disease gets FDA review

INOVIO remains confident in the therapy’s benefits and intends to meet with the FDA to discuss maintaining eligibility under this pathway

Edwards Lifesciences’ SAPIEN M3 becomes first FDA-approved transseptal mitral valve replacement

The SAPIEN M3 transcatheter mitral valve replacement (TMVR) system is designed for patients with symptomatic moderate-to-severe or severe MR

Enveda launches Phase 1 trial for first-in-class Oral IBD therapy

The Phase 1 study will evaluate the safety, tolerability, and pharmacokinetics (PK) of ENV-6946 in healthy volunteers

China approves first-in-class TGCT drug, marking global first for pimicotinib

Merck’s KEYTRUDA–Padcev combo delivers survival gains in Phase 3 bladder cancer trial

Astellas & Pfizer report breakthrough Phase 3 results in muscle-invasive bladder cancer

The combination also outperformed chemotherapy on another important secondary endpoint

ImmunityBio’s ANKTIVA wins EMA nod for early EU approval in hard-to-treat bladder cancer

Bayer launches phase III trial testing Mirena for uterine condition with no treatments

NAEH can cause heavy or abnormal bleeding and, if left untreated, may progress to uterine cancer