Genmab to Submit sBLA for Epcoritamab Plus Rituximab in FL
May 2, 2025
Decision to submit based on a positive overall response rate (ORR) (p-value < 0.0001), one of the dual primary endpoints in the Phase 3 EPCORE® FL-1
Decision to submit based on a positive overall response rate (ORR) (p-value < 0.0001), one of the dual primary endpoints in the Phase 3 EPCORE® FL-1
U.S. Food and Drug Administration approved Journavx (suzetrigine) 50 milligram oral tablets, a first-in-class non-opioid analgesic, to treat moderate to severe acute pain in adults. Journavx
A.forall announced through its U.S. subsidiary, Milla Pharmaceuticals, that it has received Abbreviated New Drug Application (ANDA) approval by the U.S. Food and Drug Administration (FDA)
VectorBuilder‘s partner, Ucello, announced that its CD19-targeting umbilical cord blood-derived allogeneic CAR-T cell therapy, UC101, received Investigational New Drug (IND) approval from the U.S. Food and
U.S. Food and Drug Administration issued a draft guidance for industry that, when finalized, will provide sponsors with recommendations for conducting multiregional clinical trials (MRCT) in support
A research led by Hong Kong Baptist University (HKBU) and the Shanghai Sixth People’s Hospital Affiliated to School of Medicine at Shanghai Jiao Tong University (Shanghai Sixth
Sumitomo Pharma America, announced today that the U.S. Food and Drug Administration (FDA) has approved GEMTESA (vibegron), a beta-3 (β3) adrenergic receptor agonist, dosed once-daily (75
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