Browsing Tag
Food and Drug Administration
35 posts
Lumos Diagnostics Holdings Limited puts FebriDx US rollout at centre of ASX:LDX rerating test
Find out how Lumos Diagnostics Holdings is using FebriDx US adoption to test whether ASX:LDX can turn regulatory wins into revenue.
British American Tobacco keeps FY26 guidance intact as $BATS market reaction exposes transition doubts
British American Tobacco lifted its Vuse and Velo outlook, but $BATS fell after group guidance stayed cautious. Find out what investors missed.
Replimune (REPL) soars 86% as WSJ says White House intervention reopens RP1 review
Replimune jumped nearly 86% after the WSJ reported White House officials pushed the FDA to reconsider twice-rejected RP1. A reopened path, and a binary bet on approval.
Is Eli Lilly (LLY) building the obesity drug supply chain nobody else can easily match?
Lilly’s obesity pipeline needs industrial muscle. Its $4.5bn Indiana bet shows why manufacturing may decide the next GLP-1 race.
PainChek just unlocked US Medicare reimbursement. Here’s what the ASX: PCK bull case looks like now
PainChek (ASX: PCK) has FDA clearance and a 30,000-bed US pipeline. Here's what the RTM reimbursement pathway means for retail investors watching PCK.
Ovarian cancer treatment options, survival rates, and the newest FDA approvals in 2026
Ovarian cancer affects 21,000 US women annually. This guide covers symptoms, staging, survival rates, BRCA risk, and the newest FDA-approved treatments through early 2026.
Corcept Therapeutics (CORT) stock in focus as ROSELLA survival data strengthen Lifyorli launch in ovarian cancer
Corcept Therapeutics strengthened its Lifyorli launch with new ROSELLA survival data. Read what this means for CORT stock and ovarian cancer treatment.
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.