ImmunityBio Holds FDA End-of-Phase Meeting on sBLA for ANKTIVA® Plus BCG in Papillary NMIBC

ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, announced that it recently held a Type B End-of-Phase meeting with the U.S. FDA...

January 21, 2026 | Wednesday | News
Valneva Voluntarily Withdraws U.S. BLA and IND for Chikungunya Vaccine IXCHIQ® Following FDA Clinical Hold

Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, announced that the Company has decided to voluntarily withdraw the biologics...

January 21, 2026 | Wednesday | News
AGC Biologics’ Milan Cell and Gene Center Strengthens Global Leadership with Waskyra™ Approval

This further establishes the global leadership of AGC Biologics' Milan Cell and Gene Center of Excellence in number of commercial products approved ...

January 20, 2026 | Tuesday | News
Apiject to Open 30,000-Square-Foot Pharmaceutical Manufacturing Facility in North Carolina

30,000-Square-Foot Facility Will Advance America's Priority to Reshore Essential Drug Manufacturing Apiject Holdings, Inc. announced the signing of a le...

January 19, 2026 | Monday | News
Atossa Therapeutics Secures FDA Orphan Drug Designation for (Z)-Endoxifen in Duchenne Muscular Dystrophy

Designation further supports (Z)-Endoxifen program into rare pediatric neuromuscular disease along with previously received Rare Pedi...

January 19, 2026 | Monday | News
Swissmedic Approves Santhera’s AGAMREE® for Duchenne Muscular Dystrophy

Santhera Pharmaceuticals (SIX: SANN) announces that the Swiss Agency for Therapeutic Products (Swissmedic), has approved AGAMREE® (vamorolone) for th...

January 16, 2026 | Friday | News
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

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