Zimmer Biomet Secures Japan PMDA Approval for World’s First Orthopedic Implants with Iodine Technology

  Zimmer Biomet Holdings, Inc., a global leader in medical technology, announced that Japan’s Pharmaceutical and Medical Devices Agency (PMDA) ...

September 26, 2025 | Friday | News
Esperion and Otsuka Secure MHLW Approval for NEXLETOL® in Japan to Treat Hypercholesterolemia

Esperion announced that Otsuka Pharmaceutical Co., Ltd. (Otsuka), the Company’s partner for the development and commercialization of NEXLETOL® ...

September 22, 2025 | Monday | News
Alvotech and Fuji Pharma Secure Japanese Approval for Three New Biosimilars: Denosumab, Golimumab, and Aflibercept

Alvotech a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced th...

September 22, 2025 | Monday | News
Ipsen Secures MHLW Approval for Bylvay® in Japan to Treat Pruritus in Progressive Familial Intrahepatic Cholestasis (PFIC)

Bylvay® is the first once-daily ileal bile acid transport inhibitor to be approved as a treatment for pruritus associated with progressive familial...

September 22, 2025 | Monday | News
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
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
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
Celaid Therapeutics and AGC Partner to Advance Scalable Expansion of iPSC-Derived Blood and Immune Cells

Celaid Therapeutics Inc. ("Celaid") have executed a collaborative research agreement with AGC Inc. ("AGC") to advance iPS cell-derived hematopoietic stem...

August 29, 2025 | Friday | News
Moderna Halts Plan for Japan mRNA API Facility Amid Market Shifts, Completes Enzymatics R&D Site at Shonan iPark

Moderna provided an update on its two planned research and manufacturing facilities at Shonan Health Innovation Park (iPark) in Fujisawa, Kanagawa Prefectu...

July 22, 2025 | Tuesday | News
AGC Introduces New Surfactant- and Fluorinated Solvent-Free Grades in AFLAS™ FFKM Series

AGC (AGC Inc., Headquarters: Tokyo; President: Yoshinori Hirai)(TOKYO:5201), a world-leading manufacturer of glass, chemicals and other high-tech materia...

July 18, 2025 | Friday | News
Japan’s Chugai and Singapore’s Gero Join Forces to Advance Antibody Therapies Targeting Aging via AI and Human Data

Collaboration to create novel antibody drug candidates using Chugai's proprietary antibody engineering technologies for drug targets identified through...

July 08, 2025 | Tuesday | News
Orchard Therapeutics Completes Global Enrollment in Pivotal MPS-IH Gene Therapy Trial Ahead of Schedule

Orchard Therapeutics, a Kyowa Kirin company, announced the last patient has been treated in a registrational trial evaluating the efficacy and safety of ...

July 08, 2025 | Tuesday | News

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