Aardvark Therapeutics Voluntarily Pauses Phase 3 HERO Trial of ARD-101 in Prader-Willi Syndrome

Aardvark Therapeutics, Inc. (Aardvark) (Nasdaq: AARD), a clinical-stage biopharmaceutical company focused on developing novel, small-molecule therapeutic...

March 02, 2026 | Monday | News
Johnson & Johnson Files for FDA Approval of IMAAVY® in Warm Autoimmune Hemolytic Anemia

Johnson & Johnson announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA), see...

March 26, 2026 | Thursday | News
Lupin Expands U.S. CNS Portfolio with FDA Approval of Brivaracetam Oral Solution

Global pharma major Lupin Limited (Lupin) (BSE: 500257) (NSE: LUPIN) (REUTERS: LUPIN.BO) (BLOOMBERG: LPCIN)   announced that it has received ap...

February 26, 2026 | Thursday | News
Dr. Reddy’s Advances Biosimilar Pipeline with FDA Review Acceptance for DRL_AB

Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as “D...

February 24, 2026 | Tuesday | News
Primera Analytical Solutions Accelerates FDA-Compliant Digital Transformation with Cenevo’s Labguru Platform

Primera Analytical Solutions (Primera), an FDA-compliant analytical Contract Research Organization (CRO), has selected Cenevo’s  Labguru electro...

February 20, 2026 | Friday | News
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

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