Kelun-Biotech’s TROP2 ADC-Immunotherapy Combo Granted Breakthrough Therapy Designation in China for First-Line NSCLC

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company") announced that its TROP2-directed antibody-drug conjugate (ADC) sacituzumab tirumo...

June 11, 2025 | Wednesday | News
European Commission Approves Italfarmaco’s Duvyzat for Duchenne Muscular Dystrophy in Ambulatory Patients

Now approved in the EU, Duvyzat offers an important treatment option for delaying Duchenne muscular dystrophy (DMD) disease progression Duvyzat is an ...

June 09, 2025 | Monday | News
Agenus and Zydus Forge Strategic Partnership to Advance BOT/BAL Immunotherapy and Launch BioCDMO Operations in the U.S.

Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, today announced it has signed definitive partnership agreements with Zydus Lifescienc...

June 05, 2025 | Thursday | News
Kura Oncology’s NDA for Ziftomenib in NPM1-Mutant AML Accepted by FDA with Priority Review

Kura Oncology, Inc.  announced the U.S. Food and Drug Administration (FDA) has accepted Kura’s New Drug Application (NDA) seeking full approva...

June 02, 2025 | Monday | News
Eton Pharmaceuticals Secures FDA Approval for KHINDIVI™, the First Oral Liquid Hydrocortisone for Pediatric Adrenal Insufficiency

Eton Pharmaceuticals, Inc (“Eton” or “the Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing an...

May 29, 2025 | Thursday | News
Mindray Unveils BeneVision V Series at Euroanaesthesia 2025, Integrating Ultrasound and Wireless Monitoring for Smarter ICU Care

 Mindray , a leading global developer of healthcare technologies, launched its BeneVision V Series patient monitoring solution at Euroanaesthes...

May 27, 2025 | Tuesday | News
Eli Lilly’s Kisunla™ (donanemab) Receives Marketing Authorization in Australia for Early Alzheimer’s Treatment

 Eli Lilly and Company  announced that the Australian Therapeutic Goods Administration (TGA) has granted marketing authorization for Kisunla (d...

May 22, 2025 | Thursday | News
Johnson & Johnson’s DARZALEX FASPRO® Receives ODAC Support for High-Risk Smoldering Multiple Myeloma

ODAC recommendation based on the positive progression-free survival and clinical benefit in the Phase 3 AQUILA study If approved, DARZALEX FASPRO® w...

May 21, 2025 | Wednesday | News
FedEx Becomes First Global Integrator to Earn CEIV Pharma Certification Across Entire Air Network

FedEx becomes first global integrator to achieve CEIV Pharma certification for ground handling across its air hubs and ramps. FedEx Corp. anno...

May 21, 2025 | Wednesday | News
FDA Commissioner Martin A. Makary Ends Double Standard, Expands Unannounced Inspections at Foreign Manufacturing Sites

  U.S. Food and Drug Administration announced its intent to expand the use of unannounced inspections at foreign manufacturing facilities that produc...

May 20, 2025 | Tuesday | News
FDA Clears First Blood Test for Alzheimer’s Diagnosis, Marking a Milestone in Early Detection and Precision Care

FDA's approved the Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio, marking a pivotal moment in the fight against Alzheimer's disease. This is the f...

May 19, 2025 | Monday | News
Fujirebio Receives FDA Clearance for First Blood-Based Test to Aid Alzheimer’s Diagnosis in the U.S.

Fujirebio announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the company’s Lumipulse® G pTau 217/&beta...

May 19, 2025 | Monday | News
Xuanzhu Biopharma’s Bireociclib Approved by NMPA Marks Breakthrough in Advanced Breast Cancer Treatment in China

National Medical Products Administration attracted widespread attention in the oncology community and the pharmaceutical market. Bireociclib tablets (tra...

May 16, 2025 | Friday | News
Align Technology Secures NMPA Approval for Invisalign® Palatal Expanders in China

Invisalign® Palatal Expanders offer doctors a removeable, safe, and clinically effective alternative to traditional palatal expanders. With Invi...

May 16, 2025 | Friday | News

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