Newsroom | 14006 results

Sorted by: Latest

FDA
-

FDA Approves BRAVECTO® QUANTUM (fluralaner for extended-release injectable suspension) from Merck Animal Health to Treat and Control Asian Longhorned Tick and Gulf Coast Tick for 12 Months in Dogs

RAHWAY, N.J.--(BUSINESS WIRE)--Merck Animal Health, known as MSD Animal Health outside the United States and Canada, a division of Merck & Co., Inc., Rahway, N.J., USA (NYSE: MRK), today announced the U.S. Food and Drug Administration (FDA) approved an expanded label for BRAVECTO® QUANTUM (fluralaner for extended-release injectable suspension) in dogs. The updated indication adds treatment and control of Asian longhorned tick (H. longicornis) and Gulf Coast tick (A. maculatum) for 12 months...
-

Nia Therapeutics Receives FDA Breakthrough Device Designation for AI-Guided Brain Implant to Treat Memory Loss

BOSTON--(BUSINESS WIRE)--Nia Theraputics' Smart Neurostimulation System is the first neurostimulation device to receive Breakthrough designation for TBI-related memory loss...
-

Eurosets Launches U.S. Commercialization of Trilly and Horizon Following FDA Clearance and Enters Strategic Partnership with Orion Medical

MEDOLLA, Italy & PLYMOUTH, Mich.--(BUSINESS WIRE)--Eurosets is pleased to announce the official start of U.S. commercialization for the Trilly and Horizon oxygenators, following successful FDA 510(k) clearance. This milestone reflects our commitment to supporting clinicians with reliable, high-performance technologies at a time when the U.S. healthcare system continues to face a critical and growing need for oxygenators and life-support solutions. Equipped with an integrated stainless-steel hea...
-

iECURE Selected for U.S. FDA Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program to Support Manufacturing Readiness of ECUR-506 Ahead of Planned BLA Submission

PHILADELPHIA--(BUSINESS WIRE)--iECURE, Inc., a clinical-stage genome editing company developing variant-agnostic in vivo targeted gene insertion therapies for the treatment of severe, inherited, neurometabolic disorders, today announced that the U.S. Food and Drug Administration (FDA) has selected ECUR-506, the company’s investigational in vivo targeted gene insertion therapy for neonatal-onset ornithine transcarbamylase (OTC) deficiency, to participate in the Chemistry, Manufacturing, and Cont...
-

Zai Lab to Present New Data on Three Internally Developed Oncology Candidates at AACR 2026, Including Zocilurtatug Pelitecan, a DLL3-Targeting Antibody-Drug Conjugate (ADC)

SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced three of the Company’s internally-developed investigational oncology therapies will be presented across four poster sessions at the upcoming American Association for Cancer Research (AACR) Annual Meeting 2026 taking place April 17-22 in San Diego, California. These next-generation candidates include: zocilurtatug pelitecan (zoci, formerly ZL-1310), a DLL3-targeting antibody-drug conjugate (A...
-

Kardigan Announces Multiple Presentations at ACC.26 from its Late-Stage Portfolio of Personalized Cardiovascular Medicines

SOUTH SAN FRANCISCO, Calif. & PRINCETON, N.J.--(BUSINESS WIRE)--Kardigan announced today that it will have multiple presentations at ACC.26, taking place on March 28-30, 2026, in New Orleans....
-

Perfuze Receives FDA Clearance for Millipede88® — the First Super-Bore Aspiration Catheter Cleared for Standalone Direct Aspiration

GALWAY, Ireland--(BUSINESS WIRE)--Perfuze, a medical device company dedicated to advancing stroke treatment through next-generation catheter technology, today announced it has received FDA 510(k) clearance for the Millipede88® Aspiration Catheter. The clearance follows the successful completion of the MARRS (Millipede AspiRation for Revascularization in Stroke) clinical study, which met all primary objectives, and positions Perfuze as a leader in the super-bore aspiration segment, the fastest-g...
-

Aldeyra Therapeutics Receives Complete Response Letter from the U.S. Food and Drug Administration for the Reproxalap New Drug Application for the Treatment of Signs and Symptoms of Dry Eye Disease

LEXINGTON, Mass.--(BUSINESS WIRE)--Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated diseases, today announced receipt of a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) of reproxalap, an investigational drug candidate, for the treatment of dry eye disease. The CRL stated that there is “a lack of substantial...
-

Cognito Therapeutics Presents New Data on Spectris™ in Alzheimer’s Disease at AD/PD™ 2026

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Cognito Therapeutics Presents New Data on Spectris™ in Alzheimer’s Disease at AD/PD™ 2026...
-

ImmunityBio Announces NCCN® Clinical Practice Guidelines in Oncology Have Been Updated to Include ANKTIVA® Plus BCG for Patients With BCG-Unresponsive NMIBC With Papillary-Only Disease

CULVER CITY, Calif.--(BUSINESS WIRE)--ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, today announced that the National Comprehensive Cancer Network (NCCN®) has updated its 2026 NCCN Clinical Practice Guidelines in Oncology for Bladder Cancer to include ANKTIVA® (nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guérin (BCG) for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary-only diseas...