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
Teva Submits NDA for Ecopipam as Potential First-in-Class Treatment for Pediatric Tourette Syndrome

NDA submission supported by positive Phase 3 data recently published in JAMA Neurology. Ecopipam is a first-in-class selective dopamine D1 receptor an...

June 22, 2026 | Monday | News
Sanofi’s Tzield Receives FDA Approval as First Disease-Modifying Therapy for Recently Diagnosed Stage 3 Type 1 Diabetes

Sanofi’s Tzield approved in the US as the first disease-modifying therapy for patients recently diagnosed with stage 3 type 1 diabetes Accelerat...

June 16, 2026 | Tuesday | News
Made Scientific and Pluristyx Partner to Streamline iPSC Therapy Development and Manufacturing

Strategic partnership integrates Pluristyx's clinical-grade iPSC platform into Made Scientific's CDMO services, giving developers a single-source path fr...

June 09, 2026 | Tuesday | News
SGS Acquires CMIC, INC. to Accelerate Growth in North America's Bioanalytical Testing Market

SGS, the world's leading testing, inspection and certification company, is pleased to announce that it has acquired CMIC, INC., a specialized provider of...

June 05, 2026 | Friday | News
Sanofi’s Venglustat Granted FDA Priority Review for Type 3 Gaucher Disease

Sanofi’s venglustat accepted for priority review in the US to treat type 3 Gaucher disease The US Food and Drug Administration (FDA) has granted p...

May 29, 2026 | Friday | News
Burges Salmon Advises PlaqueTec Limited on Oversubscribed $5 Million Fundraise to Advance BioCarta™ Cardiovascular Data Platform

The Corporate and M&A team from independent UK law firm Burges Salmon has advised PlaqueTec Limited, a Cambridge‑based medtech company pioneering int...

May 28, 2026 | Thursday | News
Lupin Receives U.S. FDA Tentative Approval for Generic Revefenacin Inhalation Solution

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

May 20, 2026 | Wednesday | News
Dr. Reddy’s Launches Canada’s First Generic Semaglutide Injection to Expand Access to Affordable GLP-1 Therapies Across G7 Markets

The launch follows Dr. Reddy’s receipt of the Notice of Compliance (NOC) from Health Canada on April 28th, 2026, marking the company’s re...

May 18, 2026 | Monday | News
CellDx-Tissue Receives US FDA Clearance, Strengthening Datar Cancer Genetics’ Global Precision Oncology and Biomarker Development Capabilities

Clearance Recognises CellDx-Tissue's Dual-Analyte DNA and RNA Workflow Across 517 Cancer-Associated Genes, with ALK, RET and ROS1 Fusion Calls on RNA-Lev...

May 18, 2026 | Monday | News
Vetter Breaks Ground on Major Saarlouis Expansion to Accelerate Global Injectable Drug Manufacturing Capacity

Ceremonial groundbreaking kicks off the first construction phase Pharmaceutical service provider advances its expansion with a 50,000 sqm facility S...

May 15, 2026 | Friday | News
Pierre Fabre Aligns with FDA on Pathway to Resubmit Tabelecleucel BLA for Rare EBV-Driven Post-Transplant Lymphoma

Pierre Fabre Pharmaceuticals, Inc. (PFP), announces it has aligned with FDA on a potential path forward for resubmission of the BLA for tabelecleucel, an...

May 11, 2026 | Monday | News
FDA Approves Once-Daily Jakafi XR for Myelofibrosis, Polycythemia Vera and GVHD

Jakafi XR is a once-daily, film-coated, extended-release formulation of Jakafi®(ruxolitinib) Once-daily Jakafi XR was shown to provide consisten...

May 05, 2026 | Tuesday | News

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