LR-19155 by LG Chem for Non-Small Cell Lung Cancer: Likelihood of Approval
Pharmaceutical Technology
JANUARY 5, 2025
LR-19155 is under clinical development by LG Chem and currently in Phase I for Non-Small Cell Lung Cancer.
Sun.Jan 05, 2025
100 
Final Rule for ACNU Arrives in Time for End of Year but Not Much New to Celebrate
FDA Law Blog
JANUARY 5, 2025
By Deborah L. Livornese As promised in the Fall Unified Regulatory Agenda, FDA issued the final rule to establish the pathway to obtain marketing approval of a nonprescription drug product with an additional condition for nonprescription use (ACNU) on December 26, 2024, before the end of the calendar year. 89 Fed. Reg. 105288 (Dec. 26, 2024). We described the 2022 proposed rule and the ten-plus year history leading up to its issuance in our blog post here.
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Trastuzumab rezetecan by Jiangsu Hengrui Medicine for Cervical Cancer: Likelihood of Approval
Pharmaceutical Technology
JANUARY 5, 2025
Trastuzumab rezetecan is under clinical development by Jiangsu Hengrui Medicine and currently in Phase II for Cervical Cancer.
How Many Calories Do You Need to Cut Each Day to Lose Weight?
AuroBlog - Aurous Healthcare Clinical Trials blog
JANUARY 5, 2025
(EyeEm Mobile GmbH/Getty Images) It’s a well-known fact that to lose weight, you either need to eat less or move more. But how many calories do you really need to cut out of your diet each day to lose weight? It may be less than you think.
From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience
Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.
The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven
GCC-4001 by Artiva Biotherapeutics for Rheumatoid Arthritis: Likelihood of Approval
Pharmaceutical Technology
JANUARY 5, 2025
GCC-4001 is under clinical development by Artiva Biotherapeutics and currently in Phase I for Rheumatoid Arthritis.
HLC-001 by Human Life CORD Japan for Coronavirus Disease 2019 (COVID-19) Associated Acute Respiratory Distress Syndrome: Likelihood of Approval
Pharmaceutical Technology
JANUARY 5, 2025
HLC-001 is under clinical development by Human Life CORD Japan and currently in Phase I for Coronavirus Disease 2019 (COVID-19) Associated Acute Respiratory Distress Syndrome.
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NMDA Regulator by Boehringer Ingelheim International for Unspecified Central Nervous System Disorders: Likelihood of Approval
Pharmaceutical Technology
JANUARY 5, 2025
NMDA Regulator is under clinical development by Boehringer Ingelheim International and currently in Phase I for Unspecified Central Nervous System Disorders.
Paclitaxel by InnoUp Farma for Solid Tumor: Likelihood of Approval
Pharmaceutical Technology
JANUARY 5, 2025
Paclitaxel is under clinical development by InnoUp Farma and currently in Phase I for Solid Tumor.
Fosigotifator by Calico Life Sciences for Unspecified Central Nervous System Disorders: Likelihood of Approval
Pharmaceutical Technology
JANUARY 5, 2025
Fosigotifator is under clinical development by Calico Life Sciences and currently in Phase II for Unspecified Central Nervous System Disorders.
Coronavirus Disease 2019 (COVID-19) vaccine by China National Biotec Group for Coronavirus Disease 2019 (COVID-19) Pneumonia: Likelihood of Approval
Pharmaceutical Technology
JANUARY 5, 2025
Coronavirus Disease 2019 (COVID-19) vaccine is under clinical development by China National Biotec Group and currently in Phase III for Coronavirus Disease 2019 (COVID-19) Pneumonia.
BNT-325 by BioNTech for Malignant Mesothelioma: Likelihood of Approval
Pharmaceutical Technology
JANUARY 5, 2025
BNT-325 is under clinical development by BioNTech and currently in Phase II for Malignant Mesothelioma.
RG-6315 by Genentech USA for Systemic Sclerosis (Scleroderma): Likelihood of Approval
Pharmaceutical Technology
JANUARY 5, 2025
RG-6315 is under clinical development by Genentech USA and currently in Phase I for Systemic Sclerosis (Scleroderma).
SMART-101 by Smart Immune for Refractory Acute Myeloid Leukemia: Likelihood of Approval
Pharmaceutical Technology
JANUARY 5, 2025
SMART-101 is under clinical development by Smart Immune and currently in Phase II for Refractory Acute Myeloid Leukemia.
SMART-101 by Smart Immune for Relapsed Acute Myeloid Leukemia: Likelihood of Approval
Pharmaceutical Technology
JANUARY 5, 2025
SMART-101 is under clinical development by Smart Immune and currently in Phase II for Relapsed Acute Myeloid Leukemia.
The New Age of Decentralized Clinical Trials
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
AKS-452 by Vakston for Coronavirus Disease 2019 (COVID-19): Likelihood of Approval
Pharmaceutical Technology
JANUARY 5, 2025
AKS-452 is under clinical development by Vakston and currently in Phase II for Coronavirus Disease 2019 (COVID-19).
SY-001 by CellOrigin Technology (Hangzhou) for Pancreatic Cancer: Likelihood of Approval
Pharmaceutical Technology
JANUARY 5, 2025
SY-001 is under clinical development by CellOrigin Technology (Hangzhou) and currently in Phase I for Pancreatic Cancer.
(Ensifentrine + glycopyrrolate) by Verona Pharma for Chronic Obstructive Pulmonary Disease (COPD): Likelihood of Approval
Pharmaceutical Technology
JANUARY 5, 2025
(Ensifentrine + glycopyrrolate) is under clinical development by Verona Pharma and currently in Phase II for Chronic Obstructive Pulmonary Disease (COPD).
LY-4052031 by Eli Lilly and Co for Ovarian Cancer: Likelihood of Approval
Pharmaceutical Technology
JANUARY 5, 2025
LY-4052031 is under clinical development by Eli Lilly and Co and currently in Phase I for Ovarian Cancer.
LY-4052031 by Eli Lilly and Co for Head And Neck Squamous Cell Carcinoma (HNSC): Likelihood of Approval
Pharmaceutical Technology
JANUARY 5, 2025
LY-4052031 is under clinical development by Eli Lilly and Co and currently in Phase I for Head And Neck Squamous Cell Carcinoma (HNSC).
GM-103 by Genemedicine for Metastatic Colorectal Cancer: Likelihood of Approval
Pharmaceutical Technology
JANUARY 5, 2025
GM-103 is under clinical development by Genemedicine and currently in Phase II for Metastatic Colorectal Cancer.
SB-207 by Pelthos Therapeutics for Genital Warts (Condylomata Acuminata): Likelihood of Approval
Pharmaceutical Technology
JANUARY 5, 2025
SB-207 is under clinical development by Pelthos Therapeutics and currently in Phase II for Genital Warts (Condylomata Acuminata).
RG-6315 by Genentech USA for Systemic Sclerosis (Scleroderma): Likelihood of Approval
Pharmaceutical Technology
JANUARY 5, 2025
RG-6315 is under clinical development by Genentech USA and currently in Phase I for Systemic Sclerosis (Scleroderma).
The New Age of Decentralized Clinical Trials
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This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.
SMART-101 by Smart Immune for Refractory Acute Myeloid Leukemia: Likelihood of Approval
Pharmaceutical Technology
JANUARY 5, 2025
SMART-101 is under clinical development by Smart Immune and currently in Phase II for Refractory Acute Myeloid Leukemia.
SMART-101 by Smart Immune for Relapsed Acute Myeloid Leukemia: Likelihood of Approval
Pharmaceutical Technology
JANUARY 5, 2025
SMART-101 is under clinical development by Smart Immune and currently in Phase II for Relapsed Acute Myeloid Leukemia.
AKS-452 by Vakston for Coronavirus Disease 2019 (COVID-19): Likelihood of Approval
Pharmaceutical Technology
JANUARY 5, 2025
AKS-452 is under clinical development by Vakston and currently in Phase II for Coronavirus Disease 2019 (COVID-19).
SY-001 by CellOrigin Technology (Hangzhou) for Pancreatic Cancer: Likelihood of Approval
Pharmaceutical Technology
JANUARY 5, 2025
SY-001 is under clinical development by CellOrigin Technology (Hangzhou) and currently in Phase I for Pancreatic Cancer.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud
(Ensifentrine + glycopyrrolate) by Verona Pharma for Chronic Obstructive Pulmonary Disease (COPD): Likelihood of Approval
Pharmaceutical Technology
JANUARY 5, 2025
(Ensifentrine + glycopyrrolate) is under clinical development by Verona Pharma and currently in Phase II for Chronic Obstructive Pulmonary Disease (COPD).
LY-4052031 by Eli Lilly and Co for Ovarian Cancer: Likelihood of Approval
Pharmaceutical Technology
JANUARY 5, 2025
LY-4052031 is under clinical development by Eli Lilly and Co and currently in Phase I for Ovarian Cancer.
LY-4052031 by Eli Lilly and Co for Head And Neck Squamous Cell Carcinoma (HNSC): Likelihood of Approval
Pharmaceutical Technology
JANUARY 5, 2025
LY-4052031 is under clinical development by Eli Lilly and Co and currently in Phase I for Head And Neck Squamous Cell Carcinoma (HNSC).
GM-103 by Genemedicine for Metastatic Colorectal Cancer: Likelihood of Approval
Pharmaceutical Technology
JANUARY 5, 2025
GM-103 is under clinical development by Genemedicine and currently in Phase II for Metastatic Colorectal Cancer.
How Machine Learning Drives Clinical Trial Efficiency
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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.
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