Supreme Court Set to Decide Future of Mifepristone: Showdown Looms Over FDA’s Endorsement
The U.S. Supreme Court is set to deliberate on the future of mifepristone, a crucial drug employed in over half of all abortions within the U.S.
Botox And Similar Injections Have Associated Risks: Consumer Group Pushes for Stronger Warnings
Consumer advocacy group Public Citizen has filed a petition with the FDA, urging the agency to demand stronger warnings regarding the risk of a potentially fatal muscle-paralyzing disease linked to Botox and similar injections.
Why Is Smoking Cessation-Focused Achieve Life Sciences Stock Trading Lower Today?
Achieve Life Sciences Inc (NASDAQ: ACHV) recently
Ascendis Pharma Announces The FDA Accepts For Review Resubmitted NDA For TransCon PTH In Adult Patients With Hypoparathyroidism
Ascendis Pharma A/S (NASDAQ:ASND) today announced that the U.S. Food & Drug Administration (FDA) has accepted for review the Company's resubmitted New Drug Application (NDA) for TransCon PTH (palopegteriparatide) for
EXCLUSIVE: Alzamend Neuro Plans To Kickstart Stress Disorder Study With Next-Gen Lithium Product Next Year
Alzamend Neuro Inc (NASDAQ: ALZN) received a "Study May Proceed" letter from the FDA for the initiation of study AL001-PTSD01, a Phase 2A study of AL001 for
Belite Bio Received Approval To Initiate Tinlarebant Phase 3 Clinical Trial For GA in Switzerland
Belite Bio, Inc (NASDAQ:BLTE), a clinical stage biopharmaceutical drug development company focused on advancing novel therapeutics targeting retinal degenerative eye diseases which have significant unmet medical needs,
FDA Approves First Gene-Editing Cell Therapy For Sickle Cell Disease, An Inherited Blood Disorder
The FDA has approved Casgevy and Lyfgenia, representing the first cell-based gene therapies for sickle cell disease in patients 12 y
Vertex And CRISPR Therapeutics Announce U.S. FDA Approval Of CASGEVY For The Treatment Of Sickle Cell Disease
– First-ever approval of a CRISPR-based gene-editing therapy in the U.S. –– Approximately 16,000 patients 12 years of age and older with severe sickle cell disease may now be eligible for this one-time treatment ––
Bluebird Bio Announces FDA Approval Of LYFGENIA For Patients Ages 12 And Older With Sickle Cell Disease And A History Of Vaso-Occlusive Events
Severe vaso-occlusive events were eliminated for 94% (30/32) of evaluable patients and all VOEs were eliminated for 88% (28/32) of evaluable patients between 6 and 18 months post-infusionLYFGENIA is the most deeply
“U.S. Approves First Gene-Editing Treatment, Casgevy, For Sickle Cell Disease” – CNBC
https://www.cnbc.com/2023/12/08/casgevy-first-crispr-gene-editing-treatment-approved-in-us.htmlThe U.S. Food and Drug Administration has approved Casgevy, the first gene-editing treatment to be marketed in the