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BioPharma Drug Approval

Every First Approval in APAC, 2026: The Full List

Asia-Pacific’s New Drug Boom: 99 Approvals, 20 World Firsts Somewhere in the second week of January, a BeOne Medicines BCL2 inhibitor called sonroto...

September 22, 2026 | Analysis

NewAmsterdam, Menarini Secure EU Approval for Obicetrapib-Based Ubeslo and Evlarco

NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or "NewAmsterdam" or the "Company"), a late-stage, clinical biopharmaceutical company developing oral, non-s...

September 23, 2026 | News

Daiichi Sankyo, AstraZeneca’s Enhertu Wins EU Panel Backing for Early Breast Cancer

Recommendation based on DESTINY-Breast05 phase 3 trial results that showed Enhertu reduced the risk of invasive disease recurrence or death by 53% vers...

September 21, 2026 | News

Japan Approves Lundbeck’s Eptinezumab for Migraine Prevention in Adults

Approval granted by Japan's Ministry of Health, Labour and Welfare (MHLW) Eptinezumab is the only intravenous (IV) CGRP-targeted preventive treatment ap...

September 18, 2026 | News

Altruist Biologics Supports LongBio Pharma’s LP-003 to NMPA BLA Acceptance in China

Enabled by Altruist's integrated CMC development platform, GMP manufacturing and regulatory service capabilities, LP-003 has successfully advanced from c...

September 17, 2026 | News

HiRO and Differentia Join Forces to Advance AI-Powered Clinical Trial Simulation and Digital Twins

Memorandum of Understanding establishes a framework for joint development of clinical trial simulation capabilities The partnership unites global clinic...

August 31, 2026 | News

US FDA Approves BeOne’s TEVIMBRA-ZIIHERA Combination for First-Line HER2+ Gastroesophageal Cancer

TEVIMBRA plus ZIIHERA and chemotherapy is the first and only immunotherapy-based regimen to deliver more than two years of median OS in first-line HER2+ ...

August 27, 2026 | News

Caliway Secures FDA IND Clearance for CBL-514–Tirzepatide Phase 2 Trial, Advances SUPREME-01 Phase 3

FDA IND Clearance for CBL-0201WR—Caliway has cleared its Investigational New Drug application for CBL-0201WR, a Phase 2 trial evaluating CBL-514 in...

August 27, 2026 | News

Leads Biolabs’ Opamtistomig NDA Accepted in China for Advanced EP-NEC

Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs" or the "Company," Stock Code: 9887.HK) today announced the Center for Drug Evaluation (CDE) of China'...

August 24, 2026 | News

Singapore HSA Approves GSK’s Blenrep Combinations for Relapsed or Refractory Multiple Myeloma

Two head-to-head phase III trials demonstrated superior efficacy, including overall survival versus a daratumumab-based triplet in DREAMM-7 Blenrep, a f...

August 20, 2026 | News

JW Pharmaceutical’s Epaminurad Shows Statistical Superiority in Phase III Gout Trial

-JW Pharmaceutical (KRX:001060) announced that the multinational Phase 3 clinical trial of its gout treatment candidate ‘Epaminurad (code name U...

August 18, 2026 | News

China Approves Geneseeq’s PanTRKare as Companion Diagnostic for VELMARTO

NMPA granted approval to Geneseeq's PanTRKare™ NTRK1/2/3 Gene Fusion Detection Kit as a companion diagnostic for VELMARTO® (Eratrectini...

August 14, 2026 | News

Alteogen Signs Up to $365 Million Hybrozyme Licensing Deal for Subcutaneous Biologic

Alteogen grants exclusive rights to develop and commercialize a subcutaneous biologic product using Hybrozyme™-based hyaluronidase ALT-B4 Alteogen...

August 07, 2026 | News

Adneuris Licenses Cebranopadol Rights to Maruishi for Japan and South Korea

Agreement Grants Maruishi Rights for the Development and Commercialization of Cebranopadol for Pain in Japan and South Korea, Marking Adneuris' Second Ex...

August 07, 2026 | News

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