Drug Approval

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

Biocon Launches Interchangeable YESAFILI Biosimilar to EYLEA in the U.S.

Yesafili™ (aflibercept-jbvf) now available in the United States as an U.S. FDA-approved interchangeable biosimilar to EYLEA 2 mg Potential ...

 August 06, 2026 | News

Ractigen's World's First saRNA Therapy for Ocular Diseases Advances to Global Clinical Development Following U.S. FDA IND Clearance

RAG-1C achieves dual IND clearances from both U.S. FDA and China CDE, paving the way for global clinical development of the world's first saRNA therapy f...

 August 03, 2026 | News

Ractigen Therapeutics Raises Over $31 Million to Advance saRNA Drug Pipeline

Ractigen Therapeutics, a clinical-stage biotechnology company pioneering small activating RNA (saRNA) therapeutics and advanced extrahepatic delivery syste...

 July 31, 2026 | News

Glenmark Launches Generic Sugammadex Injection in the US

Glenmark Pharmaceuticals Inc., USA (Glenmark)  announced the launch1 of Sugammadex Injection, 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL)...

 July 30, 2026 | News

Kelun-Biotech Advances First Dual-Payload ADC into Clinical Trials for Solid Tumours

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company", 6990.HK) announced that it has received a clinical trial notice from t...

 July 29, 2026 | News

OrbusNeich Enrols First Patient in Pivotal Japanese Trial of Coronary Drug-Coated Balloon

OrbusNeich Medical Group Holdings Limited (“OrbusNeich” or the “Group”; stock code: 6929), a multinational medical device comp...

 July 28, 2026 | News


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