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 ... Read More
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. Read More
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 Read More
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. Read More
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. Read More
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. Read More
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. Read More
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. Read More
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. Read More
NB.1.8.1 variant monitored by WHO as global spread accelerates in May 2025
NB.1.8.1 spreads across U.S., India, and China in May 2025; WHO designates as Variant Under Monitoring. No rise in severity reported yet. Read More