Milestone Pharmaceuticals Enrolls First Patient in Phase 3 Trial of Etripamil for AFib-RVR

Milestone® Pharmaceuticals Inc. , a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medi...

August 24, 2026 | Monday | News
Teva’s Ecopipam NDA Accepted by FDA for Pediatric Tourette Syndrome

Ecopipam (EBS-101) is a first-in-class selective D1 (dopamine) receptor antagonist with Orphan Drug designation NDA acceptance is supported by po...

August 21, 2026 | Friday | News
Ultragenyx Wins FDA Accelerated Approval for GENGLYCOS in GSDIa

GENGLYCOS is the first gene therapy approval, and fifth FDA approval overall, for the company Approval provides a long-awaited first-ever option to redu...

August 21, 2026 | Friday | News
FDA Seeks Input on Regulatory Framework for GenAI-Enabled Medical Devices

The U.S. Food and Drug Administration issued a discussion paper on considerations for the regulation of generative artificial intelligence (GenAI)-enable...

August 20, 2026 | Thursday | News
Radiopharm Theranostics Schedules FDA Meeting for RAD101 Phase 3 Trial

RAD 101 Phase 2b trial demonstrated 93% concordance with MRI across all evaluable lesions, meeting the Phase 2 trial's primary endpoint End-of-Phase 2 m...

August 19, 2026 | Wednesday | News
Bristol Myers Squibb Receives FDA Accelerated Approval for ZENBEXUS in Multiple Myeloma

-Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has approved ZENBEXUS™ (iberdomide) in combination with darat...

August 18, 2026 | Tuesday | News
QIAGEN Wins FDA Clearance for QIAstat-Dx Bloodstream Infection Panel

QIAstat-Dx BCID GPF Plus AMR Panel detects 20 pathogen targets and 10 antimicrobial resistance markers from positive blood cultures in about one hour...

August 12, 2026 | Wednesday | News
Fresenius Kabi Recalls Tyenne Injection Lot Over Glass Particle Contamination

Fresenius Kabi, an operating company of the Fresenius Group, is recalling one lot of Tyenne® (tocilizumab-aazg) Injection 400 mg/20 mL (20 mg/mL)20 m...

August 12, 2026 | Wednesday | News
Takeda Receives FDA Approval for ORZEYFUL to Treat Adults with Narcolepsy Type 1

Adults Taking ORZEYFUL Experienced Significant and Meaningful Improvements Across the Full Range of Symptoms of Narcolepsy Type 1 (NT1) in Clinical T...

August 07, 2026 | Friday | News
IQVIA and Medera Partner to Advance Cardiac Gene Therapy Development

IQVIA (NYSE:IQV), a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healt...

August 06, 2026 | Thursday | News
Novartis Secures FDA Approval for Pluvicto in Earlier-Stage Metastatic Prostate Cancer

Pluvicto now approved across PSMA+ metastatic prostate cancer, nearly doubling eligible patient population PSMAddition updated results show Pluvicto r...

August 04, 2026 | Tuesday | News
NeuroPace to Work with FDA After PMA Supplement for IGE Indication Receives Non-Approvable Letter

-- Company received communication from FDA indicating that the PMA Supplement for idiopathic generalized epilepsy is not approvable in its current form...

July 30, 2026 | Thursday | News
iVeena Receives FDA Support to Advance IVMED-85 into Phase 2 Trial for Pediatric Myopia

  FDA supports advancement of IVMED-85 into Phase 2 clinical development for pediatric myopia and provides alignment on key elements of the develop...

July 24, 2026 | Friday | News
FDA Approves Eisai and Biogen’s LEQEMBI IQLIK for At-Home Initiation of Alzheimer’s Treatment

LEQEMBI IQLIK is a first-of-its-kind anti-amyloid treatment worldwide, offering at-home dosing for initiation and maintenance (approved in the U.S.)...

July 15, 2026 | Wednesday | News

Survey Box

Poll of the Week

Which area of biopharmaceutical research excites you the most?

× Please select an option to participate in the poll.
Processing...
× You have successfully cast your vote.
 {{ optionDetail.option }}  {{ optionDetail.percentage }}%
 {{ optionDetail.percentage }}% Complete
More polls
Stay Connected

Sign up to our free newsletter and get the latest news sent direct to your inbox

© 2026 Biopharma Boardroom. All Rights Reserved.

Show

Forgot your password?

Show

Show

Lost your password? Please enter your email address. You will receive a link to create a new password.

Back to log-in

Close