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
Invivyd Urges FDA to Modernize COVID-19 Vaccine Evaluation Through Citizen Petition

Invivyd, Inc. announced it has submitted a Citizen Petition with the U.S. Food and Drug Administration (FDA) calling on the Agency to evolve from histori...

May 15, 2025 | Thursday | News
Biocom California and KoreaBIO Sign MOU to Strengthen US-Korea Life Science Collaboration

Biocom California, the association representing the California life science industry, and KoreaBIO, a life science trade association which seeks to solid...

May 13, 2025 | Tuesday | News
Shuttle Pharma Nears 50% Enrollment in Phase 2 Trial of Ropidoxuridine for Glioblastoma with Promising Tolerability and Completion Rates

Shuttle Pharmaceuticals Holdings, Inc. , a discovery and development stage specialty pharmaceutical company focused on improving outcomes for cancer pati...

May 09, 2025 | Friday | News

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