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
BrioHealth Solutions Granted FDA Approval to Commence Landmark Trial for Novel Heart Failure Treatment

BrioHealth Solutions, Inc., a medical technology company focused on developing innovative advanced heart failure solutions, announced it has received FDA I...

May 02, 2024 | Thursday | News
Beacon Biosignals & Takeda Forge Partnership to Elevate Sleep Disorder Biomarkers

Beacon Biosignals, the leader in at-home EEG and computational neurodiagnostics, announced a collaboration with Takeda to conduct at-home sleep monitoring ...

May 01, 2024 | Wednesday | News
ARS Pharmaceuticals Advances neffy® MAA with CHMP Response, Inks CSL Seqirus Deal for Australia & New Zealand

CHMP opinion on neffy Marketing Authorization Application anticipated in the second quarter of 2024 Response addresses all issues previously identified by...

May 01, 2024 | Wednesday | News
Celltrion USA Secures ZYMFENTRA Access Agreement with Express Scripts

Celltrion USA announced that it has signed an agreement with Express Scripts, one of the nation's leading pharmacy benefit managers (PBMs) negotiating on b...

April 29, 2024 | Monday | News
Avistone Biotechnology's Vebreltinib Granted Historic Approval for Glioma Treatment by Chinese NMPA, Paving the Way for Targeted Therapy Breakthroughs in 2024

Beijing Avistone Biotechnology Co., Ltd. (also referred to as Avistone Biotechnology or Avistone), an innovative biotechnology company focused on precision...

April 26, 2024 | Friday | News
Shanghai Junshi Biosciences' Toripalimab NDA Accepted by Hong Kong DO for Groundbreaking Nasopharyngeal Carcinoma Treatment

Shanghai Junshi Biosciences , a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel...

April 25, 2024 | Thursday | News
Zydus Launches Generic Mirabegron Extended-Release Tablets, Enhancing Access to Overactive Bladder Treatment in the US

Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as “Zydus”) announces the launch of Mirabegron Extende...

April 23, 2024 | Tuesday | News

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