Innovent, Xuanzhu Collaborate on Clinical Trial for Advanced Solid Tumors in China

Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality me...

December 28, 2023 | Thursday | News
Everest Medicines' Nefecon® NDA Accepted in Taiwan for Adult Primary IgA Nephropathy

Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the development, manufacturing and commercialization ...

December 27, 2023 | Wednesday | News
Takeda's LIVTENCITY® Approved in China for Post-Transplant CMV Treatment

Approval Based on Phase 3 TAK-620-303 SOLSTICE Study Demonstrating Maribavir Was Superior to Conventional Therapies at Week 8, for Primary Endpoint1-...

December 22, 2023 | Friday | News
FDA Approves Label Update for Yescarta® CAR T-Cell Therapy with Overall Survival Data

Kite, a Gilead Company (Nasdaq: GILD), announced that the U.S. Food and Drug Administration (FDA) has approved a label update for Yescarta® (axicabtage...

December 22, 2023 | Friday | News
Positive CHMP Opinion by EMA for Arpraziquantel to Treat Schistosomiasis in Preschool-Aged Children

EMA assessed arpraziquantel under the EU-M4all procedure for high-priority medicines intended for use in countries outside the European Union Merck is c...

December 20, 2023 | Wednesday | News
Neuronetics Receives 510(k) Clearance for NeuroSite™ Coil Placement Accessory

Neuronetics, Inc.  a medical technology company focused on designing, developing, and marketing products that improve the quality of life for patients...

December 19, 2023 | Tuesday | News
CHMP Greenlights Biogen's SKYCLARYS® for Rare Neurodegenerative Disease

Friedreich’s ataxia is a genetic, debilitating and life-shortening neuromuscular disease1 Milestone highlights Biogen’s growing portfolio in...

December 18, 2023 | Monday | News
Innovent Secures New Reimbursement Milestones for TYVYT® and BYVASDA® in China

In the updated NDRL, TYVYT® expands its coverage to the seventh new indication for the treatment of patients with epidermal growth factor receptor (EGF...

December 13, 2023 | Wednesday | News
Pfizer Receives All Required Regulatory Approvals to Complete the Acquisition of Seagen

Expects to close Seagen acquisition on December 14, 2023 Announces changes in the commercial organization to incorporate Seagen and improve focus, speed...

December 12, 2023 | Tuesday | News
Candel Therapeutics' CAN-2409 Granted FDA Fast Track for Pancreatic Cancer

“We are pleased with the FDA's decision to grant Fast Track Designation for CAN-2409 in pancreatic cancer,” said Paul Peter Tak, MD, PhD, FMedS...

December 12, 2023 | Tuesday | News
RoslinCT to manufacture first-ever US FDA approved CRISPR-based gene therapy CASGEVY™

RoslinCT, a cell and gene therapy Contract Development and Manufacturing Organisation (‘CDMO’) dedicated to developing therapies for patients w...

December 11, 2023 | Monday | News
Cyprium Transfers CUTX-101 for Menkes Disease to Sentynl, a Zydus Lifesciences Subsidiary

Cyprium received $4.5 million payment upon closing and remains eligible to receive royalties and up to $129 million in aggregate development and sales mile...

December 07, 2023 | Thursday | News
Everest Medicines' Zetomipzomib IND Accepted in China

-- Everest plans to contribute to the ongoing global Phase 2b PALIZADE trial of zetomipzomib in active lupus nephritis –  -...

December 04, 2023 | Monday | News
Junshi Biosciences' Toripalimab Application Accepted by Australia’s TGA

For the first-line treatment of adults with metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC), and for toripalimab, as a single agent...

December 04, 2023 | Monday | News

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