BioPharma Drug Approval
Breakthroughs Unveiled: A Year of Groundbreaking Novel Drug Approvals in 2023
Innovative drugs often mean new treatment options for patients and advances in health care for the American public. When it comes the development of new dr...
December 29, 2023 | News
FDA Grants Orphan Drug Designation to Boan Biotech's Two Novel Claudin 18.2 Drugs.
Orphan drugs, also known as drugs for rare diseases, are drugs for preventing, treating or diagnosing rare diseases. Being designated as orphan drugs will ...
December 28, 2023 | News
NMPA Accepts Mabwell's 8MW0511 Injection New Drug Application
8MW0511, a Class 1 therapeutic biological product, is a new generation of long-acting G-CSF (modified cytokine with high activity) with independent intelle...
December 20, 2023 | News
GC Biopharma's ALYGLO™ 10% Liquid FDA Approved for Adult Primary Immunodeficiency.
The ALYGLO pivotal phase 3 clinical study followed FDA guidance for the treatment of patients with PI. The clinical trial (NCT02783482) GC5107B was a prosp...
December 18, 2023 | News
Takeda Gets Positive CHMP Opinion for HYQVIA® in CIDP Maintenance Therapy
If Approved, HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] Would Offer an up to Once-Monthly Facilitated Subcut...
December 15, 2023 | News
Vertex Gets Positive CHMP Opinion for First CRISPR Gene Therapy, CASGEVY™, for Sickle Cell Disease
- If approved by the European Commission, patients 12 years of age and older with severe sickle cell disease or transfusion-dependent beta thal...
December 15, 2023 | News
CStone's Sugemalimab Granted NMPA Approval for Esophageal Cancer
Sugemalimab is the world's first anti-PD-L1 monoclonal antibody approved for use in combination with fluorouracil and platinum-based chemotherapy...
December 11, 2023 | News
FDA Prioritizes Review of PADCEV® Combo for Advanced Bladder Cancer
Results of pivotal confirmatory trial found the enfortumab vedotin plus pembrolizumab combination significantly extended overall survival and progres...
December 04, 2023 | News
Alecensa by Roche Cuts Risk in Asian ALK-Positive Lung Cancer Patients by Over 60%.
ALINA is the first and only Phase III study to show an improvement in disease-free survival in patients from Asia with early-stage resected ALK-posit...
December 04, 2023 | News
China Pharma Completes Third-Party Testing for Dry Eye Therapeutic Device
According to a disclosure by the Shanghai Public Health Clinical Center on June 6, 2023, an epidemiological survey of DED showed that approximately 34...
November 30, 2023 | News
Pfizer and Astellas' XTANDI® Approved by U.S. FDA in Earlier Prostate Cancer Treatment Setting
Astellas Pharma Inc. announced that the companies received an approval by the U.S. Food and Drug Administration (FDA) of a supplemental New Drug Appl...
November 27, 2023 | News
Valneva's Chikungunya Vaccine with Albumedix' Recombumin® Gets FDA Approval
Valneva's lyophilized chikungunya vaccine IXCHIQ® is the first in the world to be FDA approved against the viral disease, addressing an unm...
November 27, 2023 | News
Everest Medicines Gets NMPA Approval for Nefecon® in China for IgA Nephropathy
--Nefecon® is the first approved medicine with an IgAN indication in China-- --The approval marks a new era of IgAN treatment for Chinese patient...
November 27, 2023 | News
Ark Biopharmaceutical's AK0610 gets NMPA IND approval for RSV antibody
This antibody drug is bioengineered based on a neutralizing antibody originally isolated from a recovered child from respiratory syncytial virus (RSV) infe...
November 24, 2023 | News
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