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
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

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