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
Akeso Partner Summit Therapeutics Collaborates with Pfizer to Evaluate Ivonescimab in Combination with Pfizer’s ADCs in Solid Tumors

Akeso, Inc. ("Akeso" or the "Company") announced that its partner on ivonescimab, Summit Therapeutics Inc.  has entered into a clinical trial collabor...

February 25, 2025 | Tuesday | 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
Innovent Biologics’ Ipilimumab Injection Receives NDA Acceptance and Priority Review for MSI-H/dMMR Colon Cancer in China

Innovent Biologics, Inc., a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment o...

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
Bristol Myers Squibb Announces Positive Final Overall Survival Data for Opdivo® in Resectable NSCLC

Bristol Myers Squibb announced the final analysis of overall survival (OS) from the Phase 3 CheckMate -816 study, which evaluated Opdivo (ni...

February 21, 2025 | Friday | News
GSK Announces China’s Acceptance of New Drug Application for Nucala (Mepolizumab) as COPD Treatment

GSK plc announced that the China National Medical Products Administration has accepted for review the new drug application for the use of Nucala ...

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
Spinal Cord Injury (SCI) Cases Expected to Rise by 2034, Highlighting the Need for Improved Treatments and Support

Spinal cord injury (SCI) is a sudden disruption of the spinal cord's neural tissue within the spinal canal, caused by trauma, disease, or degeneration. Thi...

February 20, 2025 | Thursday | News
Grifols Completes Recruitment for Phase 1/2 Study of Subcutaneous Alpha1-Proteinase Inhibitor for AAT Deficiency

Grifols , a global healthcare company and leading manufacturer of plasma-derived medicines,  announced it has finished recruiting the second cohort of...

February 19, 2025 | Wednesday | News
Gilead Sciences Announces FDA Acceptance of NDA for Lenacapavir as Twice-Yearly HIV Prevention Treatment

Gilead Sciences, Inc.  announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) submissions for lenacapa...

February 19, 2025 | Wednesday | News

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