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
GeneFab and RegCell Unite to Accelerate U.S. Clinical Manufacturing of Next-Gen Treg Therapies

GeneFab, a next-generation cell and gene therapy-focused contract research, development, and manufacturing organization (CRDMO), has partnered with RegCe...

May 08, 2025 | Thursday | News
Moleculin Secures Two New U.S. Patents for Annamycin, Expanding IP Protection Through 2040

Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a late-stage pharmaceutical company with a broad portfoli...

May 06, 2025 | Tuesday | News
Australia’s Immutep Achieves 17.6-Month Survival with Chemo-Free Immunotherapy in Head and Neck Cancer

Complementary nature of these two immunotherapies leads to excellent 17.6-month median Overall Survival in head and neck cancer patients with PD-L1 CPS...

May 06, 2025 | Tuesday | News
Teva and Alvotech’s SELARSDI™ Approved by FDA as Interchangeable Biosimilar to Stelara®

The U.S. FDA has approved SELARSDI™ (ustekinumab-aekn) as interchangeable with the reference biologic Stelara® (ustekinumab) in all presentat...

May 06, 2025 | Tuesday | News
Bavarian Nordic Secures UK Approval for VIMKUNYA® Chikungunya Vaccine

Bavarian Nordic A/S announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization in the United Ki...

May 05, 2025 | Monday | News
InnoCare’s Zurletrectinib Granted Priority Review in China for NTRK Fusion-Positive Tumors

InnoCare Pharma (HKEX: 09969), a leading biopharmaceutical company for the treatment of cancer and autoimmune diseases, announced that its new generation...

May 02, 2025 | Friday | News
EU Recommends Approval of Fixed-Duration Calquence Regimen for Untreated Chronic Lymphocytic Leukaemia

A fixed-duration regimen of AstraZeneca’s Calquence (acalabrutinib) in combination with venetoclax, with or without obinutuzumab, has ...

May 01, 2025 | Thursday | News

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