HUTCHMED's Sovleplenib NDA Accepted in China for Immune Thrombocytopenia with Priority Review

— NDA accepted and granted Priority Review following its Breakthrough Therapy designation granted in January 2022 — — NDA is supported b...

January 11, 2024 | Thursday | News
Vertex Granted Approval for First CRISPR Gene-Edited Therapy, CASGEVY™, in Saudi Arabia for Sickle Cell Disease and Beta Thalassemia Treatment

-Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced  that the Saudi Food and Drug Authority (SFDA) granted Marketing Authorization for CASGE...

January 10, 2024 | Wednesday | News
European Commission Approves Pfizer's TALZENNA® with XTANDI® for Metastatic Prostate Cancer

Pfizer Inc. announced that the European Commission (EC) has approved TALZENNA® (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in c...

January 09, 2024 | Tuesday | News
India's Government Issues Updated Schedule M to Strengthen Good Manufacturing Practices in the Pharmaceutical Industry

The issuance of the amended Schedule M follows persistent advocacy from industry associations such as the Organization of Pharmaceutical Producers of India...

January 08, 2024 | Monday | News
Sail Biomedicines Secures Grants for RNA Medicines Against Malaria

-Sail Biomedicines, Inc. (“Sail” or the “Company”), a Flagship Pioneering company and leader in RNA-based programmable medicines, a...

January 04, 2024 | Thursday | News
Boston Scientific Launches AVANT GUARD Trial for FARAPULSE™ in Atrial Fibrillation

Unlike paroxysmal AF, which describes symptoms that last for seven days or fewer, persistent AF is a sustained arrhythmia that lasts for more than a week1....

January 01, 2024 | Monday | News
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

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