Ono Pharmaceutical and Deciphera Secure European Commission Approval for Vimseltinib (ROMVIMZA™) as First Therapy for TGCT in the EU

Vimseltinib is the first and only therapy with marketing authorization for the treatment of TGCT in the European Union Ono Pharmaceutical Co.,...

September 18, 2025 | Thursday | News
Nxera and Cancer Research UK Dose First Patient in Phase 2a Trial of Novel Immunotherapy Drug HTL0039732 for Advanced Solid Tumors

HTL0039732 (also known as NXE0039732) is Nxera’s novel oral EP4 antagonist being investigated to treat a wide range of solid cancers in combinati...

September 17, 2025 | Wednesday | News
Belite Bio Completes Phase 3 DRAGON Trial of Tinlarebant in Stargardt Disease

Tinlarebant has been granted Breakthrough Therapy, Fast Track, and Rare Pediatric Disease Designations in the U.S.; Orphan Drug Designation in the U.S....

September 15, 2025 | Monday | News
Lupin Secures U.S. FDA Approval for Risperidone Extended-Release Injectable Suspension with 180-Day CGT Exclusivity

Global pharma major Lupin Limited  announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Ab...

September 12, 2025 | Friday | News
Zhimeng Biopharma Receives NMPA Approval to Begin Phase 2 Trial of Novel Potassium Channel Opener CB03-154 for Refractory Epilepsy

Shanghai Zhimeng Biopharma, Inc. ("Zhimeng Biopharma") announced that its self-developed novel next-generation KCNQ2/3 potassium channel opener, CB03-154...

September 12, 2025 | Friday | News
Samsung Biologics Secures Landmark W1.8 Trillion Manufacturing Agreement with US Partner

  Samsung Biologics, South Korea’s preeminent contract development and manufacturing organisation (CDMO), has entered into a momentous W1.8 tri...

September 10, 2025 | Wednesday | News
InnoCare Pharma Wins Singapore HSA Approval for HIBRUKA Orelabrutinib in Relapsed or Refractory Marginal Zone Lymphoma

InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on cancer and autoimmune diseases, announced today that HIBRUKA ...

September 09, 2025 | Tuesday | News
Junshi Biosciences’ IL-17A Antibody JS005 Achieves Positive Phase 3 Results in Moderate-to-Severe Plaque Psoriasis

Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to th...

September 08, 2025 | Monday | News
Biocytogen and Merck Join Forces to Advance Antibody-Conjugated Lipid Nanoparticle Delivery Solutions

-Biocytogen Pharmaceuticals), a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative techn...

September 04, 2025 | Thursday | News
MEDIPAL and JCR Partner on Global Development of JR-479 for Ultra-Rare GM2 Gangliosidosis

MEDIPAL HOLDINGS CORPORATION (TSE 7459, MEDIPAL) and JCR Pharmaceuticals Co., Ltd. (TSE 4552, JCR) announced that the two companies have signed an exclus...

September 03, 2025 | Wednesday | News
Boehringer Ingelheim’s HERNEXEOS® (zongertinib) Receives NMPA Approval for HER2-Mutant Advanced NSCLC in China

Boehringer Ingelheim  announced that China’s National Medical Products Administration (NMPA) has approved HERNEXEOS® (zongertinib tablets)...

September 02, 2025 | Tuesday | News
Zai Lab Secures Hong Kong Approval for TIVDAK in Advanced Cervical Cancer

Zai Lab announced the Hong Kong Department of Health has approved TIVDAK (tisotumab vedotin-tftv) in Hong Kong for the treatment of adult patients with r...

September 02, 2025 | Tuesday | News
LOTTE BIOLOGICS Expands U.S. Footprint with Third Contract in 2025

Secures third contract this year, reinforcing global competitiveness and expanding strategic partnerships LOTTE BIOLOGICS (CEO James Park) announce...

September 02, 2025 | Tuesday | News
Eisai Receives Orphan Drug Designation in Japan for Tazverik® in Rare Epithelioid Sarcoma

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that it has received orphan drug designation for anticancer ...

September 01, 2025 | Monday | News

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