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
Anivive Secures Full FDA Approval for AI-Developed Canine Lymphoma Therapy

Anivive converts Laverdia-CA1 to full FDA approval First FDA-approved product to validate Anivive's AI-enabled development model — from drug rep...

June 29, 2026 | Monday | News
Pfizer Expands IBRANCE Label with FDA Approval in HR+, HER2+ Metastatic Breast Cancer

First and only CDK4/6 inhibitor approved for HR+ metastatic disease regardless of HER2 status Approval based on data from the collaborative Phase 3 ...

June 26, 2026 | Friday | News
Pathway Labs Launches FDA-Cleared AI ECG Tool for Early Detection of Structural Heart Disease

Pathway Labs announced its public launch of EchoNext, the world’s first FDA-approved AI detection tool that reads standard 12-lead electrocard...

June 25, 2026 | Thursday | News

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