Bio-Thera's Biosimilar Bevacizumab Avzivi® Receives Positive CHMP Opinion, Moves Closer to European Approval

Bio-Thera Solutions , a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars,  announced th...

June 05, 2024 | Wednesday | News
FDA Launches START Program to Accelerate Rare Disease Drug Development

START is a pilot program newly launched jointly by the FDA CDER and CBER divisions to further accelerate the development of novel drug and biological p...

June 03, 2024 | Monday | News
ASP Japan Secures Exclusive Sales Contract with PENTAX Medical for Innovative Endoscopy Solutions

ASP Japan LLC (hereinafter referred to as ASP Japan) was announced by HOYA Group PENTAX Europe GmbH ( hereinafter referred to as PENTAX Medical) and the ...

May 31, 2024 | Friday | News
Thermo Fisher Scientific Enhances Chromosomal Microarray Analysis Solutions to Align with IVDR Regulation

   These enhancements represent Thermo Fisher's steadfast commitment to ensuring the highest standards of safety and efficacy in cytogenetic t...

May 31, 2024 | Friday | News
European Commission Approves Opdivo® Combination Therapy for First-Line Treatment of Metastatic Urothelial Carcinoma

Bristol Myers Squibb  announced that the European Commission (EC) has approved Opdivo®(nivolumab) in combination with cisplatin and gemcitabine ...

May 30, 2024 | Thursday | News
FDA Grants Priority Review to Genentech's Inavolisib-Based Regimen for Metastatic Breast Cancer

– Priority Review recognizes the best-in-class potential of the inavolisib-based regimen for patients in urgent need of new treatment options...

May 29, 2024 | Wednesday | News
FDA Grants Priority Review to Sarclisa for Transplant-Ineligible Multiple Myeloma Treatment

  Sarclisa accepted for FDA priority review for the treatment of transplant-ineligible newly diagnosed multiple myeloma FDA Priority Review gran...

May 27, 2024 | Monday | News
Sandoz's Wyost® and Jubbonti® Gain EC Approval as Biosimilar Versions of Xgeva® and Prolia®

Wyost® (denosumab) and Jubbonti® (denosumab) approved by EC for all indications of denosumab reference medicines Xgeva® and Prolia® EC a...

May 22, 2024 | Wednesday | News
Roche and Amgen's New Lp(a) Test Receives FDA Breakthrough Device Designation

Approximately one in five people worldwide have elevated Lp(a) levels, putting them at increased risk of cardiovascular diseases including myocardial inf...

May 22, 2024 | Wednesday | News
Roche’s Inavolisib Receives Breakthrough Designation for Advanced Breast Cancer Treatment

The designation is based on Phase III INAVO120 results, showing the inavolisib-based regimen more than doubled progression-free survival compared with pa...

May 21, 2024 | Tuesday | News
Baxter’s Clinolipid Receives U.S. FDA Approval for Pediatric Use, Expanding Access to Vital Nutrition Therapy

Baxter International Inc. (NYSE: BAX), a pioneer in nutrition therapy, proudly announces the United States Food and Drug Administration (FDA) approval of a...

May 14, 2024 | Tuesday | News
HUTCHMED Initiates Registrational Phase III Clinical Trial of HMPL-306 for Relapsed / Refractory Acute Myeloid Leukemia in China

  AML, a challenging hematological malignancy, often involves mutations of IDH1 and IDH2 enzymes, necessitating innovative treatment strategies. HMPL...

May 14, 2024 | Tuesday | News
Photocure's Partner Asieris Pharmaceuticals Advances Cevira® for Potential Approval in China

Photocure ASA (OSE: PHO), the Bladder Cancer Company, announces that its partner Asieris Pharmaceuticals (SSE: 688176) communicated today that the National...

May 13, 2024 | Monday | News
Moderna's Investigational RSV Vaccine Review Delayed by FDA

Moderna, Inc. received notification from the U.S. Food and Drug Administration (FDA) regarding a delay in the review process for its investigational respir...

May 13, 2024 | Monday | 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

© 2024 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