Samsung Bioepis Reclaims European Commercial Rights for BYOOVIZ®, Expanding Direct Biosimilar Portfolio

Samsung Bioepis completes full transfer of commercial rights from Biogen back to Samsung Bioepis for BYOOVIZ® BYOOVIZ becomes the fourth biosimi...

January 05, 2026 | Monday | News
Axsome Biotherapeutics Stock Surges As FDA Grants Priority Review

Axsome Biotherapeutics announced that the US regulator has granted Priority Review to its investigational therapy for agitation associated with Alzheimer...

January 05, 2026 | Monday | News
Mabwell Secures Indonesian Approval for Adalimumab Biosimilar JUNMAIKANG

Mabwell (688062.SH), an innovation-driven biopharmaceutical company with a fully integrated industry chain, announced that its Adalimumab Injection 9MW01...

January 02, 2026 | Friday | News
FibroBiologics Files IND to Advance CYPS317 Fibroblast Spheroid Therapy into Psoriasis Trials

FibroBiologics, Inc. (Nasdaq: FBLG) (“FibroBiologics”), a clinical-stage biotechnology company with 270+ patents issued and pending with a fo...

January 02, 2026 | Friday | News
Vanda Pharmaceuticals’ Tradipitant (NEREUS™) Approved by FDA for Motion-Induced Vomiting

Vanda Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has approved NEREUS™ (tradipitant), an oral neurokinin-1 (NK-...

January 01, 2026 | Thursday | News
Diamyd Medical Aligns with FDA to Accelerate Phase 3 DIAGNODE-3 Efficacy Readout in Type 1 Diabetes

Diamyd Medical has reached alignment with the U.S. Food and Drug Administration (FDA) to accelerate the primary efficacy readout in its ongoing pivotal, ...

December 30, 2025 | Tuesday | News
Hansa Biopharma Submits FDA BLA for Imlifidase in Highly Sensitized Kidney Transplant Patients

The application is based on the successful outcome of the pivotal US Phase 3 ConfIdeS trial in highly sensitized patients Imlifida...

December 29, 2025 | Monday | News
T-MAXIMUM Pharmaceutical Secures FDA IND Clearance for Allogeneic CAR-T MT027 in Recurrent Glioblastoma

T-MAXIMUM Pharmaceutical announced that its proprietary allogeneic, B7-H3-targeted CAR-T therapy, MT027, has received IND Clearance from the U.S. Food an...

December 29, 2025 | Monday | News
Symbiosis Manufactures First 10,000-Vial Batch at New Stirling Sterile Fill-Finish Facility

Symbiosis Pharmaceutical Services (Symbiosis), a leading sterile fill finish contract manufacturing organisation (CMO), has manufactured their first 10,0...

December 24, 2025 | Wednesday | News
FNIH Secures FDA Qualification of Hip Bone Mineral Density as Surrogate Endpoint in Osteoporosis Trials

Measuring change in bone mineral density, rather than fracture occurrence, promises to speed development of new drugs to treat osteoporosis. FNIH Bi...

December 22, 2025 | Monday | News
SynaptixBio Backs FDA Priority Review Voucher Renewal as Critical Lifeline for Rare Disease Innovation

SynaptixBio, the only company licensed to commercialise a treatment for a rare, deadly disease, says the Priority Review Voucher scheme is a lifeline for...

December 22, 2025 | Monday | News
Minghui Pharma Secures FDA IND Clearance to Launch Global Phase 3 Trials of MHB018A in Thyroid Eye Disease

Minghui Pharmaceutical, a late-stage biopharmaceutical company dedicated to developing transformative medicines in immunology and oncology, today announc...

December 16, 2025 | Tuesday | News
Vanda Targets Mid-2026 Approval With Imsidolimab BLA for Generalized Pustular Psoriasis

Vanda Pharmaceuticals Inc.  announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ims...

December 16, 2025 | Tuesday | News
Savara Secures Key European Patent for MOLBREEVI as It Prepares Global Regulatory Filings

Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, announced the EPO notified the...

December 12, 2025 | Friday | News

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