Browsing Tag
United States Food and Drug Administration
193 posts
Island Pharmaceuticals (ASX: ILA) awaits FDA clearance for Galidesivir as Animal Rule review enters final phase
Island Pharmaceuticals confirms no FDA setbacks on Galidesivir. Find out what this means for its Marburg virus study and broader regulatory strategy.
How Cosette Pharmaceuticals used CGT exclusivity to unlock a long-ignored ear infection drug market
Cosette Pharmaceuticals secures FDA approval with CGT exclusivity for a long-protected otic drug. Read what this signals for specialty generics.
RemeOs DrillPin designation boosts Bioretec’s U.S. regulatory momentum in bioresorbable implants
Find out how Bioretec’s FDA Breakthrough Device Designation for its RemeOs DrillPin may reshape U.S. orthopedic fracture care and support its strategic ambitions.
ResMed advances AI sleep therapy strategy with FDA clearance of Smart Comfort for CPAP users
Discover how ResMed’s FDA-cleared Smart Comfort uses AI to personalize CPAP therapy and what this milestone means for sleep apnea care and investors.
Will UroGen Pharma’s reimbursement tailwind in 2026 turn ZUSDURI into a category-defining cancer therapy?
UroGen Pharma sets $1B peak sales goal for ZUSDURI as permanent J-code from 2026 is expected to drive widespread adoption in outpatient urology settings.
From Phase 3 data to Wall Street panic: Why MoonLake Immunotherapeutics lost 89% overnight
MoonLake’s VELA Phase 3 update rattled investors as MLTX crashed about 89%. Find out what the data really says and how week-52 could change the outlook.
Nutshell Therapeutics secures FDA IND clearance for NTS071, targeting p53 Y220C mutation in cancer treatment
Find out how Nutshell Therapeutics’ NTS071 is redefining precision oncology by targeting the p53 Y220C mutation with a novel allosteric small molecule.
Kexing Biopharm secures FDA IND approval for GB05, advancing pediatric RSV treatment
Kexing Biopharm Co., Ltd. (Stock Code: 688136.SH) has received Investigational New Drug (IND) approval from the United States…
Senores Pharmaceuticals gains FDA approval for hypertension combination therapy
Senores Pharmaceuticals Limited has received final approval from the United States Food and Drug Administration (USFDA) for its…
Zydus Lifesciences bags FDA tentative approval for Enzalutamide Tablets for prostate cancer treatment
Zydus Lifesciences Limited has secured tentative approval from the United States Food and Drug Administration (USFDA) for its…