Browsing Tag
U.S. Food and Drug Administration
103 posts
Moleculin hits key inflection point as pivotal MIRACLE Phase 3 AML trial completes treatment for first 45 patients
Find out how Moleculin Biotech’s pivotal MIRACLE Phase 3 milestone for Annamycin could reshape treatment for relapsed AML as Q1 2026 data approaches.
FDA grants RMAT designation to Senti Biosciences’ SENTI-202 after strong early AML trial results
Discover how Senti Biosciences’ SENTI-202 earned FDA RMAT designation after strong AML trial data and what it means for patients and investors.
Vyome clears final Phase 2 hurdle for VT-1953, sets stage for pivotal FDA trial in high-need cancer care
Vyome advances VT-1953 toward pivotal FDA trials after strong Phase 2 results in malignant fungating wounds. Discover the regulatory and market impact.
Incannex Healthcare secures FDA Fast Track designation for IHL-42X in obstructive sleep apnea treatment market
Find out how Incannex Healthcare’s IHL-42X earned FDA Fast Track status and why it could transform oral treatment for obstructive sleep apnea.
Alpha Tau advances alpha DaRT with FDA approval for recurrent prostate cancer study
Find out how Alpha Tau’s FDA-approved prostate cancer trial could redefine localized salvage therapy and reshape treatment for recurrent disease.
Roche secures FDA clearance and CE Mark for rapid pertussis point-of-care diagnostic test
Discover how Roche’s FDA-cleared rapid pertussis test could transform point-of-care diagnosis and reshape decentralized molecular diagnostics worldwide.
Sangamo Therapeutics wins FDA fast-track status for gene therapy ST-503 targeting small fiber neuropathy
Find out how Sangamo Therapeutics’ FDA fast-track win for ST-503 could reshape small fiber neuropathy treatment and shift biotech investor sentiment.
Major oncology milestone as Organon and Henlius secure FDA approval for POHERDY, the first U.S. biosimilar to PERJETA
Find out how FDA approval of POHERDY, the first U.S. biosimilar to PERJETA, may transform HER2-positive breast cancer treatment costs and patient access.
Is gene therapy ready for the heart? TN-201’s pause raises doubts
Find out why the FDA paused Tenaya’s gene therapy for heart disease and what it means for biotech's future in cardiac gene delivery.
Is the FDA’s hold on Intellia a warning sign for in vivo CRISPR delivery across biotech?
Intellia’s nex-z trials face FDA hold after liver safety event. Learn how its extended cash runway to mid-2027 could reshape biotech investor confidence.