BioPharma Drug Approval
Pfizer’s TALZENNA® in Combination with XTANDI® Receives U.S. FDA Approval
Pfizer (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has approved TALZENNA (talazoparib), an oral poly ADP-ribose polymerase...
June 21, 2023 | News
Sirnaomics Advances STP705 for SCCIS into Late-Stage Clinical Development
The FDA provided Sirnaomics guidance to move forward with late-stage clinical development because of the efficacious data provided as well as the widesprea...
June 20, 2023 | News
SK bioscience COVID-19 Vaccine Granted Emergency Use Listing by the World Health Organization
In a Phase III trial, the vaccine demonstrated neutralizing antibody responses against SARS-CoV-2 parental strain and had a standard safety and reactogen...
June 19, 2023 | News
FDA Approves Utidelone Injectable (UTD1) Trial for Non-Small Cell Lung Cancer
Designated as BG01-2202, this trial is a multi-national, phase 2/3, open-label, randomized, controlled clinical study of utidelone injectable (UTD1) v...
June 16, 2023 | News
C2 PHARMA Receives Approval for Digoxin China DMF, Becoming China’s Only European Supplier of This API
C2 Pharma the global leader in manufacturing and supplying ophthalmic and niche active pharmaceutical ingredients (APIs), proudly announces the appro...
June 14, 2023 | News
InnoCan Pharma Submits New Patent Applications for Advanced Pain Relief Technology
InnoCan Pharma Corporation (CSE:INNO) ("Innocan Pharma" or the "Company"), a pharmaceutical technology company leveraging its novel cannabis-bas...
June 13, 2023 | News
Biosyngen's Cell Therapy BRG01 Receives FDA Orphan Drug Designation for Nasopharyngeal Cancer Treatment
The FDA Orphan Drug Designation program grants orphan status to promising investigation drugs or biological products designed to treat, prevent or diagnose...
June 07, 2023 | News
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
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