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
InspireMD Receives FDA IDE Approval for CGUARDIANS III Trial of SwitchGuard Neuro Protection System

InspireMD, Inc. (Nasdaq: NSPR) (“InspireMD” or the “Company”), developer of the CGuard® Prime carotid stent system for the pr...

May 05, 2026 | Tuesday | News
AbbVie Confident in Rapid Path Forward After U.S. Food and Drug Administration Flags Manufacturing Issues in TrenibotE Review

U.S. Food and Drug Administration (FDA) issues Complete Response Letter (CRL) for trenibotulinumtoxinE (TrenibotE) related to manufacturing processes; ...

April 27, 2026 | Monday | News
Astellas and Pfizer Secure FDA Priority Review for PADCEV–Keytruda in Muscle-Invasive Bladder Cancer

  Submission based on statistically significant event-free and overall survival data from the Phase 3 EV-304 trial Building on the existing indica...

April 22, 2026 | Wednesday | News
Aligos Therapeutics Secures FDA Fast Track for Pevifoscorvir Sodium as Phase 2 HBV Study Advances

Received FDA Fast Track Designation for pevifoscorvir sodium for the treatment of chronic hepatitis B virus infection HBeAg- cohort sample size increa...

April 16, 2026 | Thursday | News
Renaissance Pharma Secures FDA Fast Track and IND Clearance for Daretabart in High-Risk Neuroblastoma

FDA grants Fast Track Designation for Daretabart (hu1418K322A), recognising the significant unmet medical need in high-risk neuroblastoma and enabling ...

April 15, 2026 | Wednesday | News
Mesoblast Limited Secures U.S. Food and Drug Administration IND Clearance for Registrational Trial of Ryoncil in Duchenne Muscular Dystrophy

Partnering with Parent Project Muscular Dystrophy to ensure timely access to the trial for eligible patients ~15,000 children are living with DMD in the...

April 09, 2026 | Thursday | 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