Browsing Tag
United States Food and Drug Administration
193 posts
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.
Does Priority Review signal a commercial breakthrough for Protagonist Therapeutics, Inc.?
Takeda and Protagonist secure FDA Priority Review for rusfertide in PV. Explore the strategic, financial, and competitive implications now.
Why Scholar Rock believes apitegromab could still become a major SMA therapy despite FDA delays
Scholar Rock targets a 2026 BLA resubmission and potential launch for apitegromab in spinal muscular atrophy. Discover what it means for the SMA market.