Acute Graft-Versus-Host Disease
Dec 24, 2024
FDA Approves Vertex’s ALYFTREK for Cystic Fibrosis; ZEPBOUND Gets FDA Approval for Obstructive Sleep Apnea in Obese Adults; Tonix’s TNX-102 SL NDA Accepted for Fibromyalgia; Quoin’s QRX003 Clears FDA for Netherton Syndrome Study; FDA Approves First Mesenchymal Stromal Cell Therapy for Acute GvHD
Vertex Receives US FDA Approval for ALYFTREK: A Breakthrough CFTR Modulator for Cystic Fibrosis Vertex Pharmaceuticals Incorporated announced that the FDA had approved ALYFTREK (vanzacaftor/tezacaftor/deutivacaftor), a once-daily triple combination CFTR modulator for the treatment of cystic fibrosis. ALYFTREK is...
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Aug 08, 2023
FDA Approves ZURZUVAE for Postpartum Depression; Astellas Drug Acquired in $5.9B Deal Wins FDA Approval; FDA Clearance to Phase III Study of Lisaftoclax; FDA Issues CRL to BLA Resubmission for Remestemcel-L; Bavarian Nordic Updated on its Chikungunya Virus Vaccine; FDA Orphan Drug Designation to ABM-1310
FDA Approves ZURZUVAE, the First and Only Oral Treatment Approved for Women with Postpartum Depression Biogen Inc. and Sage Therapeutics, Inc. announced that the FDA has approved ZURZUVAE (zuranolone) 50 mg for individuals with postpartum depression (PPD). ZURZUVAE is the first and only 14-day oral, once-daily t...
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Jun 23, 2023
Graft-Versus-Host Disease (GvHD) Treatment Market: A Moving Target For Therapies
Allogeneic HSCT is a mainstay for patients with different hematological malignancies, but it requires immunosuppressive strategies before and after HSCT. However, approximately half (50%) of the patients receiving allogeneic hematopoietic stem cell transplantation (HCT) from a human leukocyte antigen (HLA)-matched ...
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Feb 21, 2023
Actinium Announces Phase III SIERRA Trial Results; FDA Approves Apellis’s Geographic Atrophy Drug; FDA Gives Green Light to Chiesi’s Lamzede; FDA Accepts NDA and Grants Priority Review for Avacincaptad Pegol; FDA Approves Travere’s Kidney Disorder Drug; Takeda Presents Phase 3 GRAPHITE Study Results
Actinium Announces Positive Full Data Results From the Pivotal Phase III SIERRA Trial Actinium Pharmaceuticals, Inc., a pioneer in the development of targeted radiotherapies, announced positive primary and secondary endpoint results from its pivotal Phase III SIERRA trial of Iomab-B in patients aged 55 and older...
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