Sanofi's Dupixent® FDA Approved as First and Only Treatment for Children (1+) with Eosinophilic Esophagitis (EoE

Approval based on Phase 3 EoE KIDS trial showing a greater proportion of children taking Dupixent achieved histological remission compared to placebo&nbs...

January 26, 2024 | Friday | News
Thermo Fisher's Monza Facility Gains AIFA Approval for RNA Drug Production

Thermo Fisher Scientific, the world leader in the service of science, has received Good Manufacturing Practice (GMP) approval from the Italian Medicines Ag...

January 19, 2024 | Friday | News
EU Approves Roche's Tecentriq SC as First Subcutaneous PD-(L)1 Cancer Immunotherapy

Subcutaneous (SC) injection offers the potential for a faster, more convenient alternative to intravenous (IV) infusion and is preferred by cancer patien...

January 16, 2024 | Tuesday | News
China's RemeGen's RC88 earns FDA Fast Track, heralding new hope for ovarian cancer patients

RemeGen Co. Ltd. ("RemeGen" or "the Company") (9995.HK, 688331.SH), a commercial-stage biotechnology company, announced recently that its independently dev...

January 15, 2024 | Monday | News
Santhera Gets UK Approval for AGAMREE® (Vamorolone) in Duchenne Muscular Dystrophy Treatment

Approval by the Medicines and Healthcare products Regulatory Agency (MHRA) of AGAMREE® in the United Kingdom follows marketing authorization for this...

January 12, 2024 | Friday | News
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

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