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Drug Approval

Everest Medicines' NEFECON® sNDA Accepted by China’s NMPA, Paving the Way for First Full Approval of IgA Nephropathy Treatment

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

July 18, 2024 | News

Biosyngen's Groundbreaking CAR-T Therapy BRG01 Approved for Phase II Clinical Trial in China

Biosyngen, a leading biotechnology company focused on the development of innovative cell therapies, recently announced that the Center for Drug Evaluation ...

July 17, 2024 | News

Mabwell's Novel Nectin-4 ADC Approved for Phase II Clinical Trial in Treating Triple-Negative Breast Cancer

Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced its novel Nectin-4 targeting ADC (R&D code: 9MW2821)...

July 16, 2024 | News

ADM Korea to Submit IND for Niclosamide-Based Combination Therapy for Prostate Cancer

IND for clinical study for combination therapy with hormone therapy in prostate cancer patients to be submitted in August, 2024. Niclosamide-based metab...

July 12, 2024 | News

Eisai and Biogen Announce Approval of LEQEMBI® (Lecanemab) for Alzheimer’s Disease Treatment in Hong Kong

LEQEMBI is now available for patients with mild cognitive impairment (MCI) or mild dementia, collectively referred to as early AD, the population in which ...

July 11, 2024 | News

XPOVIO® Secures NMPA Approval for Treatment of R/R DLBCL in China, Expanding Its Indications

- Following its initial approval for the treatment of relapsed/refractory multiple myeloma (R/R MM), XPOVIO® has now received approval as a monoth...

July 08, 2024 | News

Eleva's Factor H Receives Orphan Drug Designation from European Commission for Treating C3 Glomerulopathy

Eleva, a pioneer in unlocking difficult-to-produce biologics based on a breakthrough manufacturing platform, announced today that the European Commis...

July 04, 2024 | News

European Commission Approves OBGEMSA™ (Vibegron) for Overactive Bladder Treatment by Pierre Fabre Laboratories

The European Commission (EC) has authorized the marketing of OBGEMSA™ (vibegron) by Pierre Fabre Laboratories for the symptomatic treatment of overac...

July 01, 2024 | News

South Korea Approves Reimbursement for Antengene's XPOVIO®, Expanding Access to Relapsed/Refractory Multiple Myeloma Treatment

- XPOVIO® is the first XPO1 inhibitor approved for reimbursement by South Korea's National Health Insurance Service (NHIS) for the treat...

June 27, 2024 | News

Simcere Zaiming's Enlituo® Receives NMPA Approval for mCRC Treatment

Simcere Zaiming, an innovative oncology company and a subsidiary of Simcere Pharmaceutical Group (2096.HK), announced that Enlituo® (generic name: cetu...

June 27, 2024 | News

EU Approves HUTCHMED's FRUZAQLA® for Previously Treated Metastatic Colorectal Cancer

— Approval for previously treated metastatic colorectal cancer based on results from positive, global, Phase III FRESCO-2 Trial — — FRUZ...

June 24, 2024 | News

Sarepta Therapeutics Secures FDA Approval for Expanded Use of ELEVIDYS in Duchenne Muscular Dystrophy Patients

Sarepta Therapeutics, the leader in precision genetic medicine for rare diseases, today announced U.S. Food and Drug Administration (FDA) approv...

June 21, 2024 | News

Dizal's Golidocitinib Approved in China as First JAK1-Only Inhibitor for Relapsed or Refractory Peripheral T-Cell Lymphoma

Golidocitinib is a first-in-class Janus kinase 1 (JAK1) only inhibitor approved for the treatment of r/r PTCL based on results from the multinational piv...

June 20, 2024 | News

Menarini Expands Partnership with Pharmacosmos to Bring Innovative Iron Deficiency Treatment to Singapore and Malaysia

Menarini Asia-Pacific (Menarini) announced that it has expanded its partnership with Pharmacosmos A/S (Pharmacosmos), to include exclusive rights to ...

June 19, 2024 | News

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