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FDA

InnoCare Announces FDA Approval of Clinical Trial for BCL2 Inhibitor Mesutoclax in AML and MDS

InnoCare FDA BCL2

July 14, 2025 ，InnoCare Pharma announced that FDA has approved the Investigational New Drug application to conduct the clinical trial of BCL2 inhibitor mesutoclax in combination with azacitidine for the treatment of myeloid malignancies.

July 14, 2025 by PharmaSources

Recent Job Cuts in FDA and other pharmaceutical companies, and the impact on the industry

FDA manufacturing industry job cuts

The pharma industry faces downsizing in various areas, where a number of employees are fired or relieved of their duties.In addition to the manufacturing industry, the FDA also faces job and funding cuts.

May 15, 2025 by Muhammad Asim Niazi

Comparison of Improved New Drugs Paths between China and the United States and Analysis of R&D Status in China

FDA approval 505(b)(2)

This article describes successful practices from the United States 505(b)(2) pathway and analyzes R&D status of China's modified new drugs.

April 28, 2025 by Kevin

NAD+ Application in Pharmaceutical Industry and Regulatory Status in Multiple Countries and Markets

NMN FDA NAD+

This article highlights key applications, clinical trial developments, and regulatory classifications of NAD⁺ and its derivatives across major global markets.

April 25, 2025 by Nurah Ekhlaque

Ethical and Regulatory Considerations in Personalized Medicine

Personalized Medicine FDA Gene

Personalized medicine is revolutionizing healthcare by tailoring medical treatments to individual genetic profiles, lifestyles, and environmental factors.

April 7, 2025 by Saher Haider

Pharmaceutical Cold Chain Monitoring

Cold Chain FDA Monitoring

Cold Chain is a supply chain system where product specific temperature is maintained while the it is in storage, transportation and distribution.

March 31, 2025 by Muhammad Asim Niazi

Henlius Receives Orphan Drug Designation for HLX22 in the U.S. for Gastric Cancer

Henlius FDA HLX22 ODD Gastric Cancer

Henlius announced that FDA has granted ODD for HLX22, the company's innovative anti-HER2 mAb for the treatment of gastric cancer.

March 19, 2025 by PR Newswire

Henlius Receives Orphan Drug Designation for Innovative Anti-HER2 mAb HLX22 in the U.S. for Gastric Cancer

FDA ODD HLX22

Shanghai Henlius Biotech announced that FDA has granted ODD for HLX22 for the treatment of gastric cancer.

March 19, 2025 by PR Newswire

What is Clinical Hold and how do you deal with it?

Clinical Hold IND FDA

A clinical hold is implemented for IND which is a drug stage under clinical trials to investigate its efficacy & safety, and has not been officially allowed to market & used by patients.

March 5, 2025 by Muhammad Asim Niazi

Innovent Receives Second Fast Track Designation from the U.S. FDA for IBI363 in Squamous Non-Small Cell Lung Cancer

NSCLC Innovent FDA

Innovent Receives FDA for IBI363 in Squamous Non-Small Cell Lung Cancer

February 17, 2025 by PR Newswire

Navi Medical Technologies' Neonav® ECG Tip Location System Receives FDA 510(k) Clearance

FDA Innovation Navi

FDA 510(k) Clearance Revolutionising Vascular Access Care for Critically Ill Newborns and Children

February 17, 2025 by PR Newswire

FDA Clears World's First Mobile App for Contactless Pulse Rate Measurement

PanopticAI FDA Contactless

On Jan. 26, Hong Kong - based PanopticAI announced getting FDA 510(k) clearance for its contactless vital signs monitoring software, turning mobile devices into medical - grade monitors.

January 26, 2025 by PharmaSources