Clinical Trials News

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Tecentriq® (atezolizumab) and Tecentriq Hybreza® (atezolizumab and hyaluronidase-tqjs) as an adjuvant treatment for adult patients with muscle-invasive bladder cancer (MIBC) who have circulating tumor DNA molecular residual disease (ctDNA MRD) after cystectomy, as identified by Natera’s Signatera™ CDx per...

AUSTIN, Texas--(BUSINESS WIRE)--Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced that the U.S. Food and Drug Administration (FDA) has approved Signatera CDx as a companion diagnostic (CDx) for use with adjuvant atezolizumab (Tecentriq®) immunotherapy in MIBC. This is the first companion diagnostic approval in the field of blood-based MRD. It is a significant milestone in the industry-wide shift toward personalized, MRD-guided cancer care, in...

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today announced that Week 24 and Week 48 results from the Phase 2 open-label HELIOS clinical trial of AMX0035, an oral, fixed-dose combination of sodium phenylbutyrate and taurursodiol, in adults living with Wolfram syndrome have been published in The Journal of Clinical Investigation, a peer-reviewed medical journal. The publication reports Week 24 and Week 48 results from the Phase 2 ope...

WHIPPANY, N.J.--(BUSINESS WIRE)--AUA 2026: Phase II ARASEC Data Further Supports the Efficacy and Safety of NUBEQA® (darolutamide) Plus ADT in Patients with mCSPC...

PLANO, Texas--(BUSINESS WIRE)--Secretome Therapeutics, a clinical-stage biotechnology company developing novel cellular and cell-based therapies derived from neonatal cardiac progenitor cells (nCPCs), today announced that members of its management team will participate in three upcoming investor conferences this summer. Secretome is scheduled to attend the following conferences: Jefferies Global Healthcare Conference June 2 – 4, 2026 New York, New York Oppenheimer CNS & Neuro-Muscular Summi...

PALO ALTO, Calif.--(BUSINESS WIRE)--Valar Labs, an AI precision oncology company developing diagnostics that predict cancer treatment response from routine pathology slides, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Vesta Bladder Risk Stratify Dx. With this designation, Vesta Bladder Risk Stratify Dx becomes the first AI-powered digital pathology prognostic test in bladder cancer to receive FDA Breakthrough status, marking a...

JERSEY CITY, N.J.--(BUSINESS WIRE)--Organon to present 8 abstracts on affordability, access and adoption across women’s health, biosimilar and general medicines portfolio at ISPOR 2026....

SAN DIEGO--(BUSINESS WIRE)--Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD), today announced that it will report its first quarter 2026 financial results on Monday, May 18, 2026. In connection with the earnings release, Gossamer’s management team will host a live conf...

TOKYO--(BUSINESS WIRE)--Meiji Seika Pharma reports positive Phase III Integral-1 results for nacubactam, a novel β-lactamase inhibitor, in cUTI/AP — published in The Lancet....

VANCOUVER, British Columbia & GRAPEVINE, Texas--(BUSINESS WIRE)--Alpha Cognition Inc. (ACOG: NASDAQ) (“Alpha Cognition”, “ACI”, or the “Company”), a biopharmaceutical company developing novel therapeutics for debilitating neurodegenerative disorders, today reported financial results for the first quarter ended March 31, 2026, and provided a business update. “The first quarter of 2026 marked our fourth full quarter of commercial operations for ZUNVEYL, the first new oral Alzheimer’s treatment ap...