BeiGene Wins FDA Approval for TEVIMBRA® in First-Line Esophageal Cancer Treatment

BeiGene, Ltd.  a global oncology company that intends to change its name to BeOne Medicines Ltd., announced the U.S. Food and Drug Administr...

March 06, 2025 | Thursday | News
Neurocrine Biosciences Begins Phase 1 Trial for NBI-1140675 in Neurological Disorders

Neurocrine Biosciences, Inc. announced the initiation of a Phase 1 clinical study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynami...

March 06, 2025 | Thursday | News
FDA Accepts Roche’s sBLA for Gazyva®/Gazyvaro® (Obinutuzumab) as a Treatment for Lupus Nephritis

Roche announced  that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for...

March 06, 2025 | Thursday | News
Advancements in Tenosynovial Giant Cell Tumor Treatment with Surgery and Targeted Therapies

Tenosynovial giant cell tumor, also known as pigmented villonodular synovitis (PVNS) or giant cell tumor of the tendon sheath (GCT-TS), is primarily treate...

March 05, 2025 | Wednesday | News
Myosin Therapeutics Secures Funding to Advance MT-125 for Glioblastoma, MT-110 for Addiction

 Myosin Therapeutics, Inc., a biotechnology company developing novel therapies for cancer and neurological disorders, has closed its second seed fundi...

March 04, 2025 | Tuesday | News
Telix Pharmaceuticals Announces FDA Acceptance of Biologics License Application for Breakthrough Kidney Cancer Imaging Agent TLX250-CDx

Telix Pharmaceuticals Limited  announces that the United States (U.S.) Food and Drug Administration (FDA) has accepted the Biologics License...

February 26, 2025 | Wednesday | News
Bristol Myers Squibb Announces FDA Acceptance of sBLA for Opdivo® Plus Yervoy® as First-Line Treatment for MSI-H or dMMR Metastatic Colorectal Cancer

Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental biologics license application (sBLA) for...

February 25, 2025 | Tuesday | News
Regeneron Reports Promising Results from Phase 1/2 CHORD Trial of Investigational Gene Therapy DB-OTO for Genetic Hearing Loss

Regeneron Pharmaceuticals, Inc. announced updated data for the investigational gene therapy DB-OTO from the Phase 1/2 CHORD trial in 12 children who have p...

February 25, 2025 | Tuesday | News
Johnson & Johnson Reports Positive Phase 3 ASTRO Study Data for TREMFYA® in Adults with Moderately to Severely Active Ulcerative Colitis

Johnson & Johnson announced data from the Phase 3 ASTRO study of TREMFYA® (guselkumab) subcutaneous (SC) induction therapy in adults with...

February 24, 2025 | Monday | News
Chime Biologics Advances MG-K10, Novel IL-4Rα Antibody, into U.S. Phase III Trials with Mabgeek

Chime Biologics, a leading global CDMO that enables its partners success in biologics, announced its continued collaboration with Mabgeek in adva...

February 24, 2025 | Monday | News
Novo Nordisk Announces FDA Resolution of Wegovy® and Ozempic® Supply Shortage in the U.S.

Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) has determined the shortage of Wegovy® and Ozempic® is resolved. ...

February 24, 2025 | Monday | News
Ionis Pharmaceuticals to Present New Data on Donidalorsen for Hereditary Angioedema at AAAAI/WAO Joint Congress

Ionis Pharmaceuticals, Inc.  announced that it will present additional data from the pivotal Phase 3 OASIS and OASISplus studies, as well as three yea...

February 21, 2025 | Friday | News
Phanes Therapeutics Doses First Patient in Clinical Trial of Peluntamig (PT217) for Advanced Cancers

Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company focused on innovative drug discovery and development in oncology, announced that the f...

February 20, 2025 | Thursday | News
Merilog Receives FDA Approval as the First Rapid-Acting Insulin Biosimilar

The U.S. Food and Drug Administration (FDA) approved Merilog (insulin aspart szij) as a Novolog biosimilar to (insulin aspart) to improve glycemi...

February 20, 2025 | Thursday | News

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