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
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
AVITA Medical Secures CE Mark for RECELL® GO, Expanding European Access to Innovative Burn Care

- AVITA Medical, Inc., a leading therapeutic acute wound care company,announced it has received the CE Mark under the European Union Medical Device Regul...

September 15, 2025 | Monday | 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
QIAGEN Secures CE-IVDR Certification for Full QIAstat-Dx Portfolio, Expands Syndromic Testing Panels

Full portfolio of QIAstat-Dx panels now CE-IVDR certified for use in clinical syndromic testing, underscoring commitment to highest-quality diagnosti...

September 11, 2025 | Thursday | 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
NurExone Biologic Secures US Patent Allowance for Proprietary Exosome Production Process Strengthening Global Market Position

NurExone Biologic Inc. , a pioneering biopharmaceutical company developing exosome-based regenerative therapies, is pleased to announce that the United S...

September 09, 2025 | Tuesday | News
Certara Launches Pinnacle 21 Enterprise Plus to Streamline Clinical Data Specifications and Accelerate Regulatory Submissions

Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, announced the availability of Pinnacle 21 Enterprise Plus. The solution enables clinical ...

September 05, 2025 | Friday | 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
Roche and Alnylam Target Uncontrolled Hypertension with ZENITH Phase III Trial

Phase III trial informed by comprehensive KARDIA data set generated through three Phase II studies: KARDIA-1, KARDIA-2 and KARDIA-3 In the Phase II KA...

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
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
Sanofi’s Wayrilz Wins FDA Approval as First BTK Inhibitor for Immune Thrombocytopenia

Novel treatment targets BTK through multi-immune modulation to help address root causes of ITP Approval based on LUNA 3 phase 3 study that demonstrate...

September 01, 2025 | Monday | News
Novotech and CTTQ Pharma Secure World’s First Approval of Anlotinib-Chemotherapy Combo for Advanced Soft Tissue Sarcoma

-Novotech, a globally recognized full-service clinical research organization (CRO), is proud to have partnered with Chia Tai Tianqing Pharmaceutical Grou...

August 29, 2025 | Friday | News

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