InkSpace Imaging Receives FDA Clearance for Next-Generation 1.5T 24-Channel MR Coil

InkSpace Imaging, a leader in MRI coil innovation, announced that the United States (US) Food and Drug Administration (FDA) has cleared InkSpace Imaging&rs...

January 09, 2025 | Thursday | News
Agios Pharmaceuticals Announces FDA Acceptance of Supplemental New Drug Application for PYRUKYND® in Thalassemia Treatment

Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in cellular metabolism and pyruvate kinase (PK) activation pioneering therapies for rare diseases...

January 09, 2025 | Thursday | News
GSK Secures FDA Breakthrough Therapy Designation for GSK5764227 in Relapsed Osteosarcoma

GSK plc (LSE/NYSE: GSK) announced  that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for GSK5764227 (GSK&rsq...

January 08, 2025 | Wednesday | News
Norgine Files Marketing Authorization for Eflornithine in High-Risk Neuroblastoma with EMA

Norgine announced that it completed its marketing authorisation application filing to European Medicines Agency (EMA) for eflornithine in high-risk neurobl...

January 07, 2025 | Tuesday | News
LPOXY Therapeutics to Acquire Key Assets from Xeno Biosciences to Advance C. difficile Infection Prevention Therapy

LPOXY Therapeutics, Inc. ("LPOXY"), a clinical-stage biopharmaceutical company focused on innovative therapies for infectious disease prevention, announced...

January 06, 2025 | Monday | News
Innovent Biologics and Roche Partner to Advance Novel DLL3-Targeted ADC for Small Cell Lung Cancer

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

January 02, 2025 | Thursday | News
Novartis Announces Positive Phase III STEER Study Results for OAV101 IT in Spinal Muscular Atrophy Type 2 Patients

Novartis announced positive topline results from the Phase III STEER study. This pivotal study assessed the efficacy and safety of investigational intrathe...

December 31, 2024 | Tuesday | News
BMS Gains FDA Approval for Opdivo Qvantig, First Subcutaneous PD-1 Inhibitor with Three-Minute Administration

-Bristol Myers Squibb (NYSE: BMY)  announced that the U.S. Food and Drug Administration (FDA) granted approval for Opdivo Qvantig™&nbs...

December 30, 2024 | Monday | News
FDA Approves First Generic of Victoza (Liraglutide) for Type 2 Diabetes, Expanding Access to Affordable Treatment

the U.S. Food and Drug Administration approved the first generic referencing Victoza (liraglutide injection) 18 milligram/3 milliliter, a glucagon-like pep...

December 24, 2024 | Tuesday | News
Breaking Down "Novel" Drugs: FDA’s 2024 Approval Highlights

What are "Novel" Drugs? "Novel" drugs are new drugs never before approved or marketed in the U.S.   The term "novel" drugs refers to medications ...

December 23, 2024 | Monday | News
FDA Approves ALYFTREK® (Vanzacaftor/Tezacaftor/Deutivacaftor) as Once-Daily Treatment for Cystic Fibrosis

 Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced that the U.S. Food and Drug Administration (FDA) has approved ALYFTREK (v...

December 21, 2024 | Saturday | News
FDA Approves Zepbound® (Tirzepatide) as First Treatment for Moderate-to-Severe Obstructive Sleep Apnea in Adults with Obesity

Eli Lilly and Company (NYSE: LLY) announced the U.S. Food and Drug Administration (FDA) approved Zepbound® (tirzepatide) as the fir...

December 21, 2024 | Saturday | News
FDA Approves BRAFTOVI® Combination Therapy for First-Line Treatment of Metastatic Colorectal Cancer with BRAF V600E Mutation

Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has approved BRAFTOVI® (encorafenib) in combination with cetuxi...

December 21, 2024 | Saturday | News
FDA Approves Ionis’ TRYNGOLZA™ as the First Treatment for Familial Chylomicronemia Syndrome (FCS)

 Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced that the U.S. Food and Drug Administration (FDA) has approved TRYNGOLZA™ (o...

December 20, 2024 | Friday | News

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