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
United Therapeutics Exercises Option with MannKind to Develop Second Inhaled Therapy

MannKind Corporation announced that United Therapeutics Corporation  has exercised its option—granted under the companies’ 2018 lic...

August 28, 2025 | Thursday | News
Neopharma Technologies and Orient Gene Announce Global Partnership to Digitize Drug Testing with NEOVAULT® Integration

Neopharma Technologies Limited  announced a global software licensing and collaboration agreement with Zhejiang Orient Gene Biotech Co., Ltd. ("Orie...

August 26, 2025 | Tuesday | News
Valneva Faces US FDA Suspension of IXCHIQ® Vaccine Licence After New Safety Reports

  Valneva SE , a specialty vaccine company, announced that the United States Food and Drug Administration (FDA) has suspended the license for IX...

August 26, 2025 | Tuesday | News
Alvotech and Advanz Pharma Secure European Commission Approval for Mynzepli®, a Biosimilar to Eylea®

Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Adva...

August 22, 2025 | Friday | News
Enanta Pharmaceuticals Files Patent Infringement Suit Against Pfizer in EU Unified Patent Court Over Paxlovid™

-Enanta Pharmaceuticals, Inc. (NASDAQ: ENTA), a clinical-stage biotechnology company dedicated to creating novel, small molecule drugs for viral infectio...

August 21, 2025 | Thursday | News
RemeGen and Santen Forge Strategic Alliance to Advance RC28-E for Retinal Diseases Across Asia

RemeGen Co., Ltd, a leading Chinese biopharmaceutical company, announced today that it has entered into an agreement with Santen Pharmaceutical (China) C...

August 19, 2025 | Tuesday | News
Qihan Biotech Receives FDA Clearance to Begin U.S. Trial of Universal CAR-T Therapy for Refractory Lupus

Hangzhou Qihan Biotech Co., Ltd. ("Qihan" or "Qihan Biotech" or "the Company"), an industry leader in applying multiplexable genome editing technology to...

August 19, 2025 | Tuesday | News

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