BioPharma Drug Approval
Guardant360® CDx is a comprehensive genomic profiling blood test that provides critical information to help inform personalized treatment decisi...
May 31, 2023 | News
If approved, Opdivo with chemotherapy would be the first and only neoadjuvant immunotherapy-based option authorized to treat patients with non-sm...
May 29, 2023 | Regulatory
PAXLOVID is the first FDA-approved oral treatment for COVID-19; has been authorized for emergency use since December 2021 Approval is based on the total...
May 29, 2023 | News
Orphan Drugs, also known as Rare Disease Drugs, refers to pharmaceutical products developed for the prevention, diagnosis, and treatment of rare diseases o...
May 24, 2023 | News
- ATG-031, discovered and developed in-house by Antengene, is the world's first anti-CD24 antibody to advance to the clinic in oncolog...
May 18, 2023 | News
"In just six months, we have submitted NDAs for XPOVIO® in three ASEAN countries, Malaysia, Thailand and Indonesia, supporting...
May 17, 2023 | News
This BTD for IBI351 was based on the pooled analysis of two ongoing clinical trials (NCT05005234, NCT05497336), which include 54 CRC pa...
May 15, 2023 | News
Suzhou GenAssist Therapeutic Co.,Ltd recently announced its pre-IND application of their first base editing product, GEN6050 and the acceptance by the FDA....
May 08, 2023 | News
This proprietary homogeneous nanosuspension has a solution-like appearance which offers great comfort to the eyes and enhanced drug penetration into ocular...
May 05, 2023 | News
U.S. Food and Drug Administration approved Arexvy, the first respiratory syncytial virus (RSV) vaccine approved for use in the United States. Arexvy i...
May 04, 2023 | News
This new treatment provides adults living with schizophrenia a long-acting formulation that offers flexible 1- and 2-month dosing intervals1 In a ...
May 01, 2023 | Regulatory
The proposed clinical study will involve in an evaluation of RV-1730 for its safety and prophylaxis efficacy against SARS-CoV-2 infection with people...
April 28, 2023 | News
The company has been notified by the FDA that the Phase 1/2 clinical trial may proceed The latest preclinical data explored the antitumor effica...
April 24, 2023 | News
The FDA has extended the Prescription Drug User Fee Act (PDUFA) action date by three months to July 24, 2023 to allow additional time to review requested u...
April 21, 2023 | News
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