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BioPharma Drug Approval

EFECON® Becomes First Approved Therapy for IgAN in China, Offering Hope to Millions with Improved Patient Care and Disease Management

Everest Medicines, a biopharmaceutical company focused on the discovery, clinical development, manufacturing and commercialization of innovative medicines ...

May 15, 2024 | News

Eisai's Antiepileptic Drug Fycompa® Gains Approval in China for Additional Indication

Eisai Co., Ltd. announced that it has received approval in China for the additional indication of its in-house discovered antiepileptic drug (AED) Fycompa&...

May 14, 2024 | News

Mabwell Advances Clinical Study of Nectin-4-Targeting ADC for Triple-Negative Breast Cancer

Mabwell, an innovation-driven biopharmaceutical company with entire industry chain, announced the progress of the clinical study of its novel Nectin-4-targ...

May 14, 2024 | News

Brii Biosciences Secures Breakthrough Therapy Designations for Two HBV Treatments from NMPA

Brii Biosciences Limited a biotechnology company developing therapies to improve patient health and choice across diseases with high unmet need,...

May 14, 2024 | News

SN Bioscience’s SNB-101 Receives FDA Fast Track Designation for Breakthrough Small Cell Lung Cancer Treatment

SN Bioscience Co. Ltd. (CEO Park Young-hwan) announced on May 7 that the FDA has granted Fast Track Designation for small cell lung cancer (...

May 13, 2024 | News

FDA Approves Geneoscopy's Noninvasive Colorectal Cancer Test, ColoSense

Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, announced that the U...

May 07, 2024 | News

Chipscreen's Chidamide Receives NMPA Approval for First-Line Treatment of DLBCL with MYC/BCL2 Expression

Shenzhen Chipscreen Biosciences announced that the company's lead innovative product Chidamide (Epidaza®) , an oral subtype-selective histone deacetyla...

May 01, 2024 | News

Pfizer and Genmab's TIVDAK Wins FDA Full Approval for Cervical Cancer After Outperforming Chemotherapy in Key Trial

TIVDAK is the first antibody-drug conjugate (ADC) to have positive overall survival data for patients with previously treated recurrent or metastat...

April 30, 2024 | News

EMA's CHMP Recommends Approval of Pierre Fabre's OBGEMSA™ for Overactive Bladder

Pierre Fabre Laboratories announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted ...

April 29, 2024 | News

Onconic Therapeutics Gains South Korean Approval for Innovative GERD Treatment JAQBO

Onconic Therapeutics, a leading biotechnology company in Korea, announced that the Ministry of Food and Drug Safety (MFDS) of Korea has approved JAQB...

April 26, 2024 | News

X-Therma Announces XT-Thrive® Drug Master File (DMF) Accepted by U.S. Food and Drug Administration (FDA)

"This submission was the culmination of several years of development activities and the establishment of a Good Manufacturing Practices (GMP) manufacturing...

April 19, 2024 | News

BioCity Biopharma's Cancer Therapy BC2027 Gets FDA Nod for Phase 1 Trials

BioCity Biopharma announced that the U.S. Food and Drug Administration (FDA) has cleared the company's Investigational New Drug (IND) application for a Pha...

April 10, 2024 | News

Dizal's Sunvozertinib Secures FDA Breakthrough Therapy Designation for First-Line EGFR Mutated NSCLC Treatment

Dizal announced that the U.S. Food and Drug Administration ("FDA") has granted Breakthrough Therapy Designation (BTD) to its sunvozertinib as the firs...

April 08, 2024 | News

RemeGen's Telitacicept Secures FDA Fast Track Status for Primary Sjögren's Syndrome Treatment

RemeGen , a commercial-stage biotechnology company, obtained Fast Track Designation (FTD) by the United States Food and Drug Administration (FDA) rec...

April 03, 2024 | News

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