BioArctic Partner Eisai Secures FDA Priority Review for Subcutaneous Leqembi Iqlik

BioArctic AB's (publ) (STO: BIOA B) partner Eisai announced  that the supplemental Biologics License Application (sBLA) for Leqembi Iqlik subcutaneo...

January 27, 2026 | Tuesday | News
Eisai and Biogen’s LEQEMBI IQLIK Moves Toward First At-Home Anti-Amyloid Treatment for Alzheimer’s

If approved, LEQEMBI IQLIK would be the first and only anti-amyloid treatment to offer at-home injection options for initiation and maintenance dosing fo...

January 27, 2026 | Tuesday | News
Alveus Therapeutics Advances ALV-100 Into the Clinic With FDA IND Clearance

Alveus Therapeutics, Inc. (“Alveus”), a clinical-stage biotechnology company developing next-generation therapies for obesity and metabolic d...

January 26, 2026 | Monday | News
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

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