BioPharma Drug Approval
Guardant Health's Guardant360® CDx Blood Test Approved by Singapore Health Authority for Advanced Solid Cancers
Guardant360® CDx is a comprehensive genomic profiling blood test that provides critical information to help inform personalized treatment decisi...
May 31, 2023 | News
Bristol Myers Squibb receives positive CHMP opinion for Opdivo as neoadjuvant treatment for high-risk non-small cell lung cancer
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
Pfizer's PAXLOVID™ FDA-approved for high-risk adults with severe COVID-19
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
Antengene's ATG-022 Receives Orphan Drug Designations for Gastric and Pancreatic Cancers
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
Antengene Clears U.S. IND for Phase I Trial of ATG-031 Antibody
- 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
Antengene Announces NDA Submission for XPOVIO® in Indonesia
"In just six months, we have submitted NDAs for XPOVIO® in three ASEAN countries, Malaysia, Thailand and Indonesia, supporting...
May 17, 2023 | News
Innovent's IBI351 gets NMPA breakthrough designation for advanced colorectal carcinoma
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
GenAssist's GEN6050 Base Editing Product Submits Pre-IND Application to FDA
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
Formosa Pharmaceuticals and AimMax Therapeutics Submit NDA to US FDA for APP13007 for Post-Operative Pain and Inflammation after Ocular Surgery.
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
FDA Approves First Respiratory Syncytial Virus (RSV) Vaccine
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
FDA Approves Teva and MedinCell's UZEDY™ for Adult Schizophrenia Treatment
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
RNAimmune's RV-1730 COVID-19 booster vaccine receives FDA clearance for Phase 1 trial.
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
Bridge Biotherapeutics Receives FDA Approval for First-in-Human Study of BBT-207, a 4th Gen EGFR TKI.
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
Quizartinib NDA Review for Patients with Newly Diagnosed FLT3-ITD Positive AML Extended by FDA
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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