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BioPharma Drug Approval

Sichuan Kelun Biotech Secures NMPA IND Approval For SKB105 Antibody Drug Conjugate In Advanced Solid Tumours

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company", 6990.HK) announced that its Investigational New Drug (IND) appli...

January 07, 2026 | News

ScinoPharm Taiwan Becomes First In Country To Secure US FDA Approval For Multiple Sclerosis Injection

ScinoPharm Taiwan announced a landmark achievement in the global pharmaceutical landscape, securing U.S. Food and Drug Administration (FDA) approval for Gl...

January 06, 2026 | News

CivicaScript Expands Affordable Biosimilar Access With Insulin And Ustekinumab Launches

CivicaScript®, LLC, a nonprofit company dedicated to bringing low-cost generic medicines and biosimilars to U.S. patients, announced the availabi...

January 06, 2026 | News

Samsung Bioepis Takes Full Control Of BYOOVIZ Commercialisation In Europe

Samsung Bioepis completes full transfer of commercial rights from Biogen back to Samsung Bioepis for BYOOVIZ® BYOOVIZ becomes the fourth biosimila...

January 05, 2026 | News

INOVIO BLA For INO 3107 Accepted By FDA With Standard Review Timeline

INOVIO, a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer,...

January 02, 2026 | News

Intas Pharmaceuticals Limited Secures Exclusive Needle Free Injection Technology For IVF And Gynecology In India

Intas Pharmaceuticals Limited (“Intas”), a leading multinational pharmaceutical company, has entered into an exclusive agreement with ...

December 30, 2025 | News

Sobi Secures Positive CHMP Opinion For Aspaveli In Rare Kidney Diseases

Approximately 8,000 people in Europe are living with C3G or primary IC-MPGN If approved, Aspaveli (pegcetacoplan) would be the first C3G and primary IC-...

December 30, 2025 | News

Japan Approves Sephience For All Ages Marking First PTC Product Clearance In The Country

– Indication includes all ages and the full spectrum of disease severity –– First Japan product approval for PTC – PTC T...

December 30, 2025 | News

EMA CHMP Backs Gotenfia Golimumab Biosimilar Advancing STADA and Bio Thera European Strategy

Positive opinion from European Medicines Agency supports approval for golimumab biosimilar Gotenfia® developed by Bio-Thera and to be marke...

December 30, 2025 | News

2025 Drug Approvals, Decoded: What Every Biopharma Leader Needs to Know

At the centre of this momentum stood the U.S. Food and Drug Administration, whose 2025 approvals illustrated how medicine is moving decisiv...

December 29, 2025 | Analysis | By arcilla.fran@biopharmaapac.com

China Approves First Dual Immunotherapy Neoadjuvant Regimen For MSI H dMMR Colon Cancer

TABOSUN® (ipilimumab N01 injection) has been approved in combination with TYVYT® (sintilimab injection) for the neoadjuvant treatment o...

December 26, 2025 | News

SN Bioscience Secures US FDA Orphan Drug Designation For SNB 101 In Gastric Cancer

SN Bioscience Inc. (CEO Young Hwan PARK) announced that the FDA had granted Orphan Drug Designation (ODD) on December 10 for gastric cancer (incl...

December 25, 2025 | News

Italfarmaco Partners With JCR Pharmaceuticals To Advance Givinostat Development And Commercialisation In Japan

Italfarmaco grants JCR Pharmaceuticals exclusive rights to develop and commercialise givinostat in Japan - - Additional strategic collaboration in rare ...

December 25, 2025 | News

Everest Medicines Secures FDA Approval For LEROCHOL In Hypercholesterolemia

Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing, a...

December 18, 2025 | News

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