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Drug Approval

Telix Pharmaceuticals Submits NDA to FDA for Innovative Brain Cancer Imaging Agent Pixclara®

Telix Pharmaceuticals announces it has submitted a New Drug Application (NDA) to the United States (U.S.) Food and Drug Administration (FDA) for ...

August 28, 2024 | News

Yipurun's Corina System Receives Approval in China for Treating Moderate-to-Severe Intrauterine Adhesions

Corina Intrauterine Drug-Eluting System ("Corina"), developed by Yipurun (Shanghai) Biotechnology Co., Ltd. ("YPR"), has received approval i...

August 26, 2024 | News

Kelun-Biotech's NDA for Sacituzumab Tirumotecan Accepted by China's NMPA Following Positive Lung Cancer Study Results

New drug application (NDA) for the core product sacituzumab tirumotecan (sac-TMT, formerly SKB264/MK-2870) based on the positive results from the pivotal O...

August 21, 2024 | News

AbbVie Secures EU Approval for TEPKINLY® as First Subcutaneous Bispecific Antibody for Relapsed Follicular Lymphoma

AbbVie announced that the European Commission (EC) has granted conditional marketing authorization for TEPKINLY® (epcoritamab) as a monotherapy fo...

August 20, 2024 | News

AbbVie Secures EU Approval for TEPKINLY® as First Subcutaneous Bispecific Antibody for Relapsed Follicular Lymphoma

AbbVie announced that the European Commission (EC) has granted conditional marketing authorization for TEPKINLY® (epcoritamab) as a monotherapy fo...

August 20, 2024 | News

Astellas Pharma Gains NMPA Approval for PADCEV™ in China to Treat Advanced Urothelial Cancer

Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, "Astellas") announced that the Center for Drug Evaluation (CDE) of C...

August 20, 2024 | News

Akeso’s Ivonescimab Granted Priority Review by China's NMPA for First-Line Treatment of PD-L1 Positive NSCLC

Akeso, Inc. announced that the National Center for Drug Evaluation of the State Drug Administration of the People's Republic of China (NMPA CDE) ...

August 15, 2024 | News

UAE Approves LEQEMBI® for Early Alzheimer’s Treatment, Marking a Milestone in Regional Healthcare

Eisai Co., Ltd. and Biogen Inc. announced today that the Ministry of Health and Prevention in the United Arab Emirates (UAE) has approved humanized anti-so...

August 14, 2024 | News

GSK Singapore Secures HSA Approval for Jemperli Combo Therapy in Advanced Endometrial Cancer

GSK Singapore is pleased to announce that the Singapore Health Sciences Authority (HSA) has approved a new indication for Jemperli (dostarlimab). Jemperli ...

August 07, 2024 | News

FDA Grants Rare Pediatric Disease Designation to META Pharmaceuticals' Investigational Drug META-001-PH

META Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) to its investiga...

August 06, 2024 | News

Pierre Fabre Laboratories Receives Positive CHMP Opinion for BRAFTOVI® + MEKTOVI® in Advanced NSCLC Treatment

Pierre Fabre Laboratories announced that the Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval ...

July 29, 2024 | News

Sugemalimab Becomes First Anti-PD-L1 mAb Approved in Europe for First-Line Treatment of NSCLC

Sugemalimab becomes the world's first anti-PD-L1 monoclonal antibody (mAb) approved in Europe for first-line treatment of both squamous and non...

July 29, 2024 | News

IASO Biotechnology's IND Application for IASO-782 Injection Approved by NMPA for Systemic Lupus Erythematosus Treatment

IASO Biotechnology ("IASO Bio"), a biopharmaceutical company dedicated to discovering, developing, manufacturing and commercializing innovative cell therap...

July 26, 2024 | News

FDA Accepts Telix's NDA for TLX007-CDx, Expanding PSMA-PET Imaging Access

Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) announces that the United States (U.S.) Food and Drug Administration (FDA) has...

July 24, 2024 | News

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