FDA News

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...

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....

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...

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...

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

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...

LOS ANGELES--(BUSINESS WIRE)--Flosonics Medical, maker of FloPatch, the world’s first wireless, wearable Doppler ultrasound for critical care, today announced the peer-reviewed publication of the Safe and Fluid Effective Resuscitation (SaFER) protocol in SN Comprehensive Clinical Medicine. Co-authored by Flosonics co-founder and CMO Dr. Jon-Emile Kenny and Stanford University’s Dr. Carolyn Kaufman, the paper introduces a structured bedside framework for IV fluid decisions and identifies FloPatc...

ALEXANDRIA, Va. & MIAMI--(BUSINESS WIRE)--AAO-HNSF and OpenEvidence use AI to update clinical practice guidelines and align standards of care with the latest clinical evidence as it evolves....

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced screening and enrollment are underway in Cohort 8 of ENDEAVOR (Study 9001-103). The purpose of Cohort 8 is to assess prophylactic sirolimus treatment as part of an enhanced safety protocol during treatment with ELEVIDYS (delandistrogene moxeparvovec-rokl) in non-ambulant individuals with Duchenne muscular dystrophy. Data from Cohort 8 will be u...

PALO ALTO, Calif. & HONG KONG--(BUSINESS WIRE)--Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced the launch of the Shield™ multi-cancer detection (MCD) laboratory developed test (LDT) in multiple markets in Asia. The Shield MCD test is a methylation-based blood test for the detection of multiple cancer types including bladder, colorectal, breast, prostate, esophageal, gastric, liver, lung, ovarian and pancreas cancer in individuals aged 45 or older who a...