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Drug Approval

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 26, 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

GenSci, RTW And Yarrow Forge US Focused Biotech Partnership To Advance First In Class Thyroid Autoimmune Therapy

Collaboration to focus on building a leading, US-based biotech dedicated to addressing underserved patients impacted by autoimmune and endocrinology di...

December 17, 2025 | News

Formation Bio Acquires Global Rights To CNS Penetrant TYK2 Inhibitor LNK01006

Lynk Pharmaceuticals Co., Ltd. (hereinafter referred to as "Lynk Pharmaceuticals") and Formation Bio announced Formation Bio's acquisition of wor...

December 11, 2025 | News

Innovent Biologics Seven Innovative Therapies Included in China’s 2025 National Reimbursement Drug List

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

December 08, 2025 | News

Kelun Biotech And Crescent Biopharma Forge Global Partnership To Advance Next Generation Oncology Therapies

Companies to advance CR-001, a PD-1 x VEGF bispecific antibody, and SKB105, an integrin beta-6-directed antibody-drug conjugate (ADC), in global markets an...

December 05, 2025 | News

Formosa Pharmaceuticals Grants Exclusive ASEAN Rights For APP13007 To Rxilient Medical

Taiwan-based Formosa Pharmaceuticals ("Formosa", 6838.TW) announced that the company has entered into an exclusive licensing agreement with Rxil...

December 04, 2025 | News

Antengene Secures Expanded Approvals For Xpovio In Hong Kong Across Multiple Myeloma And DLBCL

- XPOVIO® (selinexor) has received approvals for three indications in Hong Kong. These include its previous approval as the treatment for mul...

December 04, 2025 | News

Samsung Bioepis Gains CHMP Backing for BYOOVIZ Pre Filled Syringe

European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopts positive opinion for BYOOVIZ® (ranibizuma...

December 03, 2025 | News

Ascletis Advances First Oral Triple Agonist for Obesity, ASC37, into Clinical Development

- Utilizing Ascletis' Peptide Oral Transport ENhancement Technology (POTENT), ASC37 oral tablets achieved average absolute oral bioavailability ...

December 01, 2025 | News

IASO Bio Achieves Landmark Hong Kong Approval for Fucaso CAR-T Therapy

IASO Biotechnology ("IASO Bio"), a commercial-stage biopharmaceutical company dedicated to the discovery, development, manufacturing, and commerciali...

November 28, 2025 | Regulatory

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