AHB-137 gains Breakthrough Therapy Designation (BTD) from the NMPA based on Phase 1/Phase2a clinical trial data demonstrating safety and efficacy. BTD...
BioArctic AB is pleased to announce that its partner, Eisai, has received approval from the Department of Health in Hong Kong for Leqembi® (bra...
Roche announced that it has received the CE Mark for its Accu-Chek® SmartGuide continuous glucose monitoring (CGM) solution. This signifi...
HUTCHMED (China) Limited (“HUTCHMED”) announces that the New Drug Application (“NDA”) for tazemetostat for the treatment of...
Global biotechnology leader CSL Behring announced that two hemophilia B patients were treated with the gene therapy HEMGENIX® (etranacogene dez...
Vanza triple granted priority review with Prescription Drug User Fee Act (PDUFA) target action date of January 2, 2025 – - EU Marketing Authorizat...
Kisunla slowed cognitive and functional decline by up to 35% compared to placebo at 18 months in its pivotal Phase 3 study and reduced participants' risk...
Samsung Bioepis Co., Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for PYZCHIVA&re...
SCG Cell Therapy Pte Ltd (SCG), a biotechnology company developing novel immunotherapies for infectious diseases and their associated cancers, today anno...
Cepheid announced today that it has received FDA De Novo marketing authorization and Clinical Laboratory Improvement Amendments (CLIA) Waiver approval for ...
Regulatory review of the single-dose CHIKV VLP vaccine candidate for immunization to prevent disease caused by chikungunya virus infection in individua...
The status is based on preclinical data and data from an ongoing phase 1/2 study for BNT324/DB-1311; preliminary phase 1/2 clinical data showed anti-tu...
Takeda announced that LIVTENCITY® (maribavir) has been approved by the Japanese Ministry of Health, Labour and Welfare (MHLW) for post-transplant cy...
AbbVie announced that the U.S. Food and Drug Administration (FDA) has approved SKYRIZI® (risankizumab-rzaa) for adults with moderately to severely ac...
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