Browsing Tag
U.S. Food and Drug Administration
166 posts
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.
Gene therapy dreams on hold? Inside the FDA move that rattled Tenaya Therapeutics
Find out why the FDA paused Tenaya’s TN-201 trial for heart disease and what this could mean for gene therapy investors and the company’s future.
Regeneron’s Libtayo wins FDA approval as first adjuvant immunotherapy for high-risk skin cancer patients
Find out how Regeneron’s Libtayo is redefining skin cancer care as the first FDA-approved adjuvant immunotherapy for high-risk CSCC patients
How Spruce Biosciences’ tralesinidase alfa could become the first disease-modifying therapy for Sanfilippo syndrome type B
Find out how Spruce Biosciences is redefining enzyme replacement therapy with its FDA-designated tralesinidase alfa for Sanfilippo syndrome type B.
Liquid biopsy breakthrough: FDA okays Guardant360 CDx to match patients to Eli Lilly’s Inluriyo
FDA approves Guardant360 CDx as a companion diagnostic for Inluriyo in ESR1-mutated breast cancer. Discover how liquid biopsy is reshaping oncology care today.
Johnson & Johnson wins FDA approval for Tremfya in pediatric psoriasis and psoriatic arthritis
Johnson & Johnson wins FDA approval for Tremfya in pediatric psoriasis and psoriatic arthritis, extending its immunology lead and boosting growth prospects.
Novo Nordisk seeks FDA nod for Mim8 — how will this impact hemophilia treatment and NVO stock?
Novo Nordisk files FDA application for Mim8 in hemophilia A. Learn how flexible dosing and trial data could redefine the bleeding disorder market.
Eli Lilly wins FDA approval for Inluriyo in ESR1-mutated metastatic breast cancer
FDA approves Eli Lilly’s Inluriyo for ESR1-mutated breast cancer, boosting oncology pipeline and investor confidence. Learn how this reshapes treatment.