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
Sanofi Wins FDA Approval for Subcutaneous Sarclisa Escena with On-Body Injector

Sanofi’s subcutaneous Sarclisa Escena approved in the US as first anticancer treatment administered via on-body injector Sarclisa Escena admini...

July 14, 2026 | Tuesday | News
Elevar Therapeutics Receives FDA Complete Response Letter for Rivoceranib-Camrelizumab NDA

Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating treatment...

July 14, 2026 | Tuesday | News
FDA Expands Padcev–Keytruda Approval, Broadening Treatment Options for Muscle-Invasive Bladder Cancer

The US Food and Drug Administration (FDA) has expanded the approved indication for the Padcev (enfortumab vedotin) and Keytruda (pembrolizumab) combination...

July 13, 2026 | Monday | News
FDA Expands Approval of Vertex’s CASGEVY to Children Aged Two and Older with Sickle Cell Disease and Beta Thalassemia

- First and only approved genetic therapy to treat children as young as 2 years for both severe sickle cell disease and transfusion-dependent beta thal...

July 03, 2026 | Friday | Regulatory
Viridian Therapeutics Secures FDA Approval for Lumvoa, the First Treatment for Both Active and Chronic Thyroid Eye Disease

First approved treatment for thyroid eye disease (TED) with labeling that includes data for both active and chronic TED - - In two pivotal phase 3 cli...

June 30, 2026 | Tuesday | News

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