MEDIPOST Inc. Files IND Amendment to Advance Phase III Stem Cell Therapy Trial for Knee Osteoarthritis

MEDIPOST Inc., a biotechnology company developing allogeneic, umbilical cord blood-derived stem cell therapies for inflammation-driven degenerative disea...

February 16, 2026 | Monday | News
Novocure Advances Pancreatic Cancer Care with FDA Approval of Optune Pax®

Optune Pax concomitant with gemcitabine and nab-paclitaxel is the first treatment to be FDA approved in nearly 30 years for locally advanced pancreatic...

February 13, 2026 | Friday | News
Agilent PD L1 IHC 22C3 PharmDx Secures FDA Approval To Guide KEYTRUDA In Ovarian Cancer

Approval expands PD-L1 testing to support treatment decisions with KEYTRUDA® (pembrolizumab)1, 2 Agilent Technologies Inc. announced ...

February 13, 2026 | Friday | News
Trace Biosciences Receives FDA IND Clearance for First Nerve-Specific Fluorescent Imaging Agent

Trace Biosciences, Inc., a clinical-stage biotechnology company developing nerve-targeted imaging agents,  announced that the U.S. Food and Drug Adm...

February 03, 2026 | Tuesday | News
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

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