Australia’s CSL Prices Hemophilia Gene Therapy at $3.5M
Australian drugmaker CSL Ltd (CSL.AX), opens new tab on Tuesday set the list price of its one-time gene therapy for hemophilia B at $3.5…
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BioMarin Finally Secures FDA Approval of Hemophilia Gene Therapy
After a prolonged journey, the medicine, known as Roctavian, is now cleared for certain patients with hemophilia A, the more common form of the…
Bluebird Wins FDA Approval of Gene Therapy For Rare Brain Disorder
The Food and Drug Administration on Friday granted accelerated approval to a personalized gene therapy for an ultra-rare childhood brain disease, called cerebral adrenoleukodystrophy…
Bluebird’s $2.8M Gene Therapy Becomes Most Expensive Drug
The U.S. Food and Drug Administration on Wednesday approved bluebird bio's (BLUE.O), opens new tab gene therapy for patients with a rare disorder requiring…
BMS CAR-T Therapy Wins FDA Approval for Expanded Use
Following back-to-back approvals in lymphocytic leukemia, Bristol Myers Squibb’s CAR-T therapy Breyanzi on Wednesday won the FDA’s green light for relapsed or refractory follicular…
Bristol Myers Secures Another FDA Go-Ahead For Breyanzi
In the years since gaining an initial FDA approval for Breyanzi, Bristol Myers Squibb has worked hard to expand the reach of its cell…
Bristol’s Breyanzi Wins Broader FDA Nod, Bringing CAR-T Showdown
The FDA has cleared Bristol Myers’ Breyanzi to treat newly relapsed or refractory large B-cell lymphoma (LBCL). The nod comes less than three months after Yescarta became first…
Carbon Branch Advisory Statement — Claim Payment Integrity
False Claims Act Settlements and Judgments Exceed $2.68 Billion in Fiscal Year 2023 - Highest Number of Settlements and Judgements in History
FDA Approves Aucatzyl for Adults with Aggressive Leukemia
Aucatzyl is a CAR T-cell therapy that targets CD19 and has been designed to minimize excessive activation of the programmed T cells. The wholesale…
