JCR Pharmaceuticals Completes Enrollment in Global Phase III Trial of JR-141 for Hunter Syndrome Across the U.S., Latin America, and Europe

-JCR Pharmaceuticals Co., Ltd. (TSE 4552; JCR) announced that it achieved the enrollment of the target number of participants in the global Phase III cli...

July 03, 2025 | Thursday | News
Carthera’s SonoCloud® Wins EMA Endorsement as Orphan Medical Device for Recurrent Glioblastoma

Carthera, a spin-off from Sorbonne University founded by Pr. Alexandre Carpentier, and developer of SonoCloud®, an innovative ultrasound-based med...

July 02, 2025 | Wednesday | News
HUTCHMED and AstraZeneca Secure China Approval for ORPATHYS®–TAGRISSO® Combination in EGFR-Mutant NSCLC with MET Amplification

HUTCHMED (China) Limited  announces that the New Drug Application (“NDA”) for the combination of ORPATHYS® (savolitinib) and TAGRISS...

July 01, 2025 | Tuesday | News
Sanofi’s Riliprubart Secures FDA Orphan Drug Status for AMR in Transplants; Phase 2 Kidney Study Underway

Ongoing phase 2 study evaluating riliprubart for the potential prevention and treatment of active antibody-mediated rejection in kidney transplant reci...

June 25, 2025 | Wednesday | News
Alvotech and Advanz Pharma Receive CHMP Positive Opinion for AVT06, a Proposed Biosimilar to Eylea®

Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Adva...

June 24, 2025 | Tuesday | News
Ipsen’s Cabometyx® Receives Positive CHMP Opinion for Advanced Neuroendocrine Tumors

Ipsen  announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion...

June 23, 2025 | Monday | News
Bayer Submits US FDA Application for Gadoquatrane, a Low-Dose MRI Contrast Agent

FDA submission seeks approval for investigational gadolinium-based contrast agent (GBCA) gadoquatrane for contrast-enhanced magnetic resonance imagin...

June 18, 2025 | Wednesday | News
Sarepta Halts ELEVIDYS Shipments for Non-Ambulatory Duchenne Patients After Second Fatal Case of Acute Liver Failure

Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today provided a safety update regarding ELEVIDYS (...

June 16, 2025 | Monday | News
EMA Committee Backs Merck Animal Health’s NUMELVI as First Second-Generation JAK Inhibitor for Canine Allergic Dermatitis

If Approved, NUMELVI Will Be the First and Only Second-Generation Janus Kinase (JAK) Inhibitor for the Treatment of Pruritus Associated with Allergic D...

June 13, 2025 | Friday | News
Persica Secures EU Patent for PP353 Targeting Chronic Low Back Pain

Persica Pharmaceuticals Limited (Persica), a clinical stage biotechnology company developing a transformative treatment for chronic Low Back Pain (cLBP),...

June 12, 2025 | Thursday | News
Kelun-Biotech’s TROP2 ADC-Immunotherapy Combo Granted Breakthrough Therapy Designation in China for First-Line NSCLC

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company") announced that its TROP2-directed antibody-drug conjugate (ADC) sacituzumab tirumo...

June 11, 2025 | Wednesday | News
European Commission Approves Italfarmaco’s Duvyzat for Duchenne Muscular Dystrophy in Ambulatory Patients

Now approved in the EU, Duvyzat offers an important treatment option for delaying Duchenne muscular dystrophy (DMD) disease progression Duvyzat is an ...

June 09, 2025 | Monday | News
Agenus and Zydus Forge Strategic Partnership to Advance BOT/BAL Immunotherapy and Launch BioCDMO Operations in the U.S.

Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, today announced it has signed definitive partnership agreements with Zydus Lifescienc...

June 05, 2025 | Thursday | News
Kura Oncology’s NDA for Ziftomenib in NPM1-Mutant AML Accepted by FDA with Priority Review

Kura Oncology, Inc.  announced the U.S. Food and Drug Administration (FDA) has accepted Kura’s New Drug Application (NDA) seeking full approva...

June 02, 2025 | Monday | News

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