Three antibiotics, three different AMR battles: why Innoviva’s Prix Galien triple could matter beyond the awards
Innoviva’s XACDURO, ZEVTERA and NUZOLVENCE reach the 2026 Prix Galien finals, spotlighting a growing anti-infective portfolio.
Pharma & Biotech
Medical Devices & Diagnostics
Restylane Shaype has cleared Europe, but can Galderma turn its “bone-mimicking” filler into a new chin-shaping standard?
Galderma’s Restylane Shaype gains EU MDR approval for chin augmentation, bringing its high-firmness NASHA HD filler into Europe.
Pharma & Biotech
VCN-01 moves toward Phase 2/3 retinoblastoma trial after Theriva completes study design
Theriva designs a Phase 2/3 VCN-01 retinoblastoma trial after early eye-preservation signals. See what the planned FDA meeting could change.
Pharma & Biotech
LB-102 pivotal trial accelerates as LB Pharmaceuticals expands psychiatric pipeline
LB-102 Phase 3 schizophrenia data are now due in H1 2027 as faster enrollment and $150m financing accelerate LB Pharmaceuticals’ pipeline.
Pharma & Biotech
FDA endorsement moves once-weekly sutacimig into decisive Glanzmann thrombasthenia study
Sutacimig gets an FDA-backed Phase 3 path after sustained bleed reductions in Glanzmann thrombasthenia. Read what the pivotal trial must prove.
Pharma & Biotech
SEP-479 clears first pharmacokinetic hurdle in pursuit of oral hypoparathyroidism therapy
SEP-479 shows a 3-to-4-day half-life in Phase 1, supporting once-daily oral dosing. See what Septerna must prove next in hypoparathyroidism.
Pharma & Biotech
Tenax heart failure drug fails Phase 3 test despite 49% drop in cardiac stress biomarker
TNX-103 misses its Phase 3 LEVEL endpoints as Tenax shares collapse. See why a 26.3-meter subgroup benefit could keep the program alive.
Pharma & Biotech
NCX 470 moves toward China approval with U.S. review already underway
NCX 470 enters China regulatory review after two positive Phase 3 glaucoma trials. Read why U.S. and China decisions could reshape Nicox.
Pharma & Biotech
Quantum BioPharma gets FDA clearance to advance Lucid-MS into Phase 2 progressive multiple sclerosis trial
Quantum BioPharma Ltd. (NASDAQ: QNTM) said on August 10, 2026 that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug programme for Lucid-MS, also known as Lucid-21-302, allowing the company to proceed with a randomized, double-blind, placebo-controlled Phase 2 study in progressive multiple sclerosis. The regulatory decision permits clinical development to
Medical Devices & Diagnostics
Labcorp gets FDA approval for PGDx elio tissue complete CDx in BRAF-mutated melanoma
Labcorp Holdings Inc. (NYSE: LH) announced on August 10, 2026 that the U.S. Food and Drug Administration has approved PGDx elio tissue complete CDx as a companion diagnostic for identifying melanoma patients whose tumors carry BRAF V600E or BRAF V600K mutations and who may benefit from FDA-approved BRAF inhibitors or approved BRAF and MEK inhibitor