Facioscapulohumeral Muscular Dystrophy
Jun 30, 2026
Zymeworks Announces Acquisition of Theravance Biopharma; Ipsen to Acquire Kartos Therapeutics; Viridian Therapeutics Wins U.S. FDA Approval for Lumvoa; Replimune Reaches FDA Milestone with RP1 BLA Resubmission Acceptance; Epicrispr Announces Encouraging Clinical Data for EPI-321 in FSHD
Zymeworks Signs Definitive Agreement to Acquire Theravance Biopharma Zymeworks Inc. has signed a definitive agreement to acquire Theravance Biopharma, Inc., marking a strategic step in expanding its commercial portfolio. The acquisition will bring YUPELRI®, the first and only once-daily nebulized long-acting mus...
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Jun 16, 2026
Ultomiris Receives US Priority Review for Adult IgA Nephropathy Treatment; FDA Approves WELIREG Plus KEYTRUDA or KEYTRUDA QLEX for Adjuvant Treatment of Select ccRCC Patients; Jazz Pharmaceuticals Highlights Phase 3 LAGOON Trial Update for Zepzelca® in Second-Line SCLC; Novartis’ delpacibart braxlosiran (del-brax) Achieves Primary Biomarker Endpoint in Phase I/II FSHD Study; Takeda’s Zasocitinib Tops Deucravacitinib in Phase 3 Psoriasis Trial, Setting a New Benchmark for Oral Therapies; IMAAVY Demonstrates Clinically Meaningful and Sustained Hemoglobin Responses in Pivotal wAIHA Study
Ultomiris Secures Priority Review Status in the US for Adult IgA Nephropathy Alexion, AstraZeneca Rare Disease announced that the FDA has accepted and granted Priority Review to the supplemental Biologics License Application (sBLA) for Ultomiris as a potential treatment for adults with Immunoglobulin A Nephropat...
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Apr 08, 2025
Amgen’s UPLIZNA Wins First FDA Nod for IgG4-Related Disease; Aldeyra Gets FDA CRL for Reproxalap in Dry Eye; Novartis’ Vanrafia Snags Accelerated FDA OK for IgAN Proteinuria; Biogen’s BIIB080 Earns Fast Track for Alzheimer’s; Epicrispr’s EPI-321 Cleared by FDA for FSHD
Amgen’s UPLIZNA Becomes First FDA-Approved Treatment for IgG4-Related Disease Amgen announced that the FDA has approved UPLIZNA (inebilizumab-cdon) as the first and only treatment for adults with Immunoglobulin G4-related disease (IgG4-RD), a rare and chronic immune-mediated inflammatory condition that can affec...
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Nov 21, 2023
Key Updates on Phase 1 Trial of AB-1005 Gene Therapy for Multiple System Atrophy-Parkinsonian Type; European Commission Approves EBGLYSS; Bayer Stopped OCEANIC-AF Study; Pfizer and Astellas’ XTANDI Approved by FDA; FDA Orphan Drug Designation to Epic Bio’s EPI-321; FDA Fast Track Designation to Chemomab’s CM-101 for PSC
AskBio Announces First Patient Randomized in Phase 1 Trial of AB-1005 Gene Therapy for Multiple System Atrophy-Parkinsonian Type Asklepios BioPharmaceutical, Inc., a gene therapy firm fully owned and independently operated under Bayer AG, announced the initiation of the Phase I REGENERATE MSA-101 clinical trial ...
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