Browsing Tag
Food and Drug Administration
38 posts
Archer Materials (AXE) advances Biochip to beta prototype as silicon-first strategy targets clinical validation
Archer Materials (ASX: AXE) advances its Biochip medical diagnostic to beta prototype, targeting clinical trials via silicon-first strategy and Stage 2 imec partnership. Read the full analysis.
LightStim and Hand & Stone roll out FDA-cleared Elipsa nationwide as LED facials go mainstream
LightStim and Hand & Stone are taking FDA-cleared Elipsa nationwide. Read how the rollout could reshape professional LED skincare access.
Why Context Therapeutics (NASDAQ: CNTX) jumped on CTIM-76 fast track status and what comes next
Context Therapeutics stock rose after CTIM-76 won FDA fast track status. Read what it means for CNTX, ovarian cancer strategy, and the June 2026 data catalyst.
RadNet Inc. (NASDAQ: RDNT) strengthens clinical AI strategy with Gleamer acquisition and 46–56% Digital Health growth forecast
RadNet Inc. (RDNT) targets 17–19% imaging growth and $140M digital ARR after acquiring Gleamer. See what this means for AI in radiology.
Why HeartBeam’s 510(k) appeal could reshape cardiac software approval timelines
HeartBeam outlines a dual-track regulatory strategy after FDA setback on ECG software. See how it plans to unlock clearance and stay on track for market entry.
Immuron secures FDA greenlight to begin human studies of IMM-529 against C. difficile infection
Immuron gains FDA IND approval for IMM-529, advancing its oral antibody therapy into human trials for C. difficile infection.
Bladder cancer breakthrough: FDA gives Priority Review to Merck’s KEYTRUDA and KEYTRUDA QLEX + PADCEV combinations
Find out how Merck’s KEYTRUDA and new KEYTRUDA QLEX + PADCEV combinations are set to transform treatment for muscle-invasive bladder cancer — read more now
H2 Global Group enters growth phase with hydrogen therapy for Alzheimer’s and neurodegenerative diseases
H2 Global Group eyes EU and FDA milestones as it advances hydrogen therapy for Alzheimer’s and projects $48M revenues by 2029—read the in-depth analysis.
Apiject seeks FDA approval for prefilled single-dose injection device using blow-fill-seal technology
Apiject files for FDA approval of its BFS-based prefilled injection device, aiming to cut costs, reduce foreign reliance, and reshape global drug delivery.
Mifepristone under fire: RFK Jr. orders FDA review of abortion pill used in most U.S. procedures
RFK Jr. orders FDA review of mifepristone, the abortion pill used in two-thirds of U.S. abortions. Explore the stakes for access, politics, and regulatory integrity.