Browsing Tag
United States Food and Drug Administration
45 posts
Could Pixclara become the missing imaging tool in U.S. glioma care after FDA NDA acceptance?
Could Pixclara transform U.S. glioma imaging after FDA NDA acceptance? Explore what Telix Pharmaceuticals Limited’s September catalyst could change next.
Replimune Group (NASDAQ: REPL) plans layoffs after FDA rejects Tudriqev again, forcing a biotech reset
Replimune plans layoffs after the FDA rejected Tudriqev again. Read what the setback means for REPL stock, cash runway, strategy, and rivals.
Why platinum-resistant ovarian cancer remains a high-stakes proving ground for CDH6-targeted ADCs
Can SIM0505 change NextCure’s oncology outlook? Read why platinum-resistant ovarian cancer is the key test case for 2026.
Is Sun Pharmaceutical (NSE: SUNPHARMA) now a wait-for-results stock or an M&A rerating story?
Sun Pharmaceutical (NSE: SUNPHARMA) faces Q4 results, tariff risk, and the Organon bid. Read what could move the stock next.
Vanda Pharmaceuticals (VNDA) bets on GLP-1 adherence gap with new Nereus vomiting-prevention study
Vanda Pharmaceuticals has launched the Thetis study to test Nereus in GLP-1-related vomiting. Read what this means for obesity drug adherence and VNDA.
How the FDA meeting could redefine pelareorep’s registrational path in anal cancer
Could Oncolytics Biotech redefine pelareorep’s approval path in anal cancer? Read what the FDA meeting means for commercialization and investor sentiment.
Why Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) just strengthened the Eylea HD case against Roche’s Vabysmo
Regeneron won FDA approval for every-20-week Eylea HD dosing in wet AMD and DME. Read what it means for Regeneron, rivals, and retinal drug markets.
Incyte (NASDAQ: INCY) moves closer to an hidradenitis suppurativa launch as 54-week povorcitinib data hold up
Incyte Corporation’s new 54-week povorcitinib data could reshape hidradenitis suppurativa treatment. Read what it means for INCY now.
FDA engagement signals cautious progress for AEON Biopharma Inc. in complex biologics space (NYSE American: AEON)
AEON Biopharma advances ABP-450 biosimilar strategy. Discover what this means for BOTOX competition, pricing, and biotech market dynamics.
United Therapeutics (NASDAQ: UTHR) pushes inhaled therapy strategy as Phase 3 Tyvaso data shows lung function preservation in IPF
United Therapeutics reports strong Phase 3 TETON-2 results for Tyvaso in idiopathic pulmonary fibrosis. Discover why this inhaled therapy could reshape treatment.