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FDA approves Pfizer’s first gene therapy for rare inherited bleeding disorder
The Food and Drug Administration approved Pfizer's treatment for a rare genetic bleeding disorder, making it the company's first ... gene therapy for the more common hemophilia A. Pfizer also ...
LinkedIn1mon
Pfizer gene therapy gets FDA OK
Pfizer won approval from the Food and Drug Administration for its first gene therapy, Beqvez, to be used by patients with the rare bleeding disorder, hemophilia B. The drug, a one-time treatment ...
healthandpharma1mon
Transformative One-Time Gene Therapy: FDA Approves Pfizer's BEQVEZ, for Hemophilia B
Pfizer announced that the US Food and Drug Administration (FDA) has approved ... Pfizer. Pfizer's commitment to hemophilia treatment extends beyond BEQVEZ, the company is actively developing other ...
The Pharma Letter1mon
FDA approves Pfizer’s gene therapy Beqvez for adults with hemophilia B
The US Food and Drug Administration (FDA) has approved Beqvez (fidanacogene elaparvovec-dzkt), a gene therapy for hemophilia B. Developed by US pharma giant Pfizer (NYSE: PFE), Beqvez is authorized ...
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FDA approves Labcorp companion diagnostic for Pfizer gene therapy
The US Food and Drug Administration (FDA ... Pfizer’s combination regimen of Braftovi (encorafenib) and Mektovi (binimetinib). "FDA approves Labcorp companion diagnostic for Pfizer gene therapy ...
Nasdaq1mon
U.S. FDA Approves Pfizer’s BEQVEZ™ (fidanacogene elaparvovec-dzkt), a One-Time Gene Therapy for Adults with Hemophilia B
About BENEGENE-2 The FDA ... a gene therapy, including its potential benefits and an approval in the U.S. of BEQVEZ for the treatment of adult patients with hemophilia B, and Pfizer’s other ...
The Huntsville Item1mon
U.S. FDA Approves Pfizer’s BEQVEZ™ (fidanacogene elaparvovec-dzkt), a One-Time Gene Therapy for Adults with Hemophilia B
Pfizer Inc. (NYSE: PFE) announced today that the U.S ... the FDA and EMA, respectively. About BEQVEZ (fidanacogene elaparvovec-dzkt) BEQVEZ is an adeno-associated virus (AAV)-based gene therapy ...
rarediseaseadvisor18d
FDA Approves Companion Diagnostic for Hemophilia B Gene Therapy
“Labcorp is proud to offer the first cell-based, companion diagnostic to receive FDA approval ... role in Pfizer’s program by identifying preexisting neutralizing antibodies against the ...
The Pharma Letter1d
FDA approves expanded use of Besponsa
The US Food and Drug Administration (FDA) late yesterday approved Pfizer’s (NYSE: PFE) antibody drug conjugate Besponsa (inotuzumab ozogamicin) to include patients one year of age and older with ...
hemophilianewstoday16d
Hemophilia B gene therapy Beqvez offers new choice: Pfizer official
Pfizer is preparing to launch its hemophilia B gene therapy Beqvez (fidanacogene elaparvovec-dzkt) after securing a U.S. approval for the treatment last month. Beqvez is the second gene therapy to be ...
devdiscourse21h
Health News Roundup: Trodelvy Bladder Cancer Trial Disappoints, Pfizer’s Lung Drug Succeeds
US FDA staff ... over the therapy's benefits and risks by the U.S. Food and Drug Administration's advisory panel on Tuesday, ...