Browsing Tag
Food and Drug Administration
25 posts
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.
Supreme Court says retailers can sue FDA over vape bans, citing NCLA in key ruling
Find out how the U.S. Supreme Court’s FDA vape ban ruling secures court access for retailers and cites the New Civil Liberties Alliance's amicus brief.
Booster drop-off alarms health officials as NB.1.8.1 and LP.8.1 variants gain ground
WHO flags sharp global drop in COVID-19 booster uptake amid rising NB.1.8.1 and LP.8.1 variants; CDC, India, U.K. ramp up fall vaccination planning.
Fall 2025 COVID booster update: FDA endorses JN.1-based vaccine as dominant LP.8.1 strain spreads
FDA backs fall 2025 COVID booster targeting LP.8.1; rollout to begin by August. New vaccine expected to offer stronger protection against dominant variants.