Browsing Tag
Food and Drug Administration
38 posts
Could elsunersen become the asset that steadies Praxis Precision Medicines’ CNS pipeline?
Find out how Praxis’ FDA Breakthrough Therapy Designation for elsunersen could affect PRAX stock, rare epilepsy strategy and precision neuroscience today!
Could TSHA stock gain momentum as Taysha advances TSHA-102 toward a Rett syndrome BLA?
Find out how Taysha’s TSHA-102 Rett syndrome update could affect TSHA stock, BLA planning and rare disease gene therapy competition today!
Is the gMG treatment race entering a lower-burden dosing phase?
Find out how Regeneron’s cemdisiran review could reshape generalized myasthenia gravis treatment, REGN stock sentiment and siRNA competition today!
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.