Browsing Tag
Food and Drug Administration
41 posts
US medical groups fill CDC policy gap with independent 2026-27 respiratory vaccine recommendations
Major US medical groups issue independent flu, COVID-19 and RSV vaccine guidance as the traditional CDC recommendation process remains unsettled.
Amgen data breach: Patient records exposed via third-party cloud storage
Amgen said patient health data was exfiltrated via third-party cloud storage in an incident deemed material days before its August 4 Q2 earnings release.
Intuitive Surgical (NASDAQ: ISRG) beats on every Q2 metric but stock falls 10% as guidance holds firm
Intuitive Surgical beat Q2 estimates with $2.89B revenue and $2.80 non-GAAP EPS, but ISRG fell ~10% after hours as procedure guidance stayed at 13.5%–15.5%.
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.