Brand & Product Security

Articles

The partnership revolves around meeting various agency standards and industry requirements pertaining to the drug development and manufacturing lifecycle. 

ValGenesis, RxCloud Collaborate on Tackling Compliance and Quality Assurance Challenges

Xolair (omalizumab) was previously granted FDA Priority Review status and Breakthrough Therapy Designation to prevent severe allergic reactions after accidental exposure to one or more foods in people with allergies. 

FDA Approves First Treatment for Multiple Food Allergies in Adults, Children 

Tepmetko (tepotinib), an oral MET inhibitor, was granted accelerated approval in 2021 for metastatic non–small cell lung cancer harboring MET exon 14 skipping alterations.

FDA Grants Full Approval to Tepmetko for Metastatic NSCLC Subtype 

There were no safety or efficacy issues identified in the FDA complete response letter for Lymphir, with no additional trials required.

Citius Pharmaceuticals Resubmits BLA to Address Product Testing, Manufacturing Controls Identified in FDA Complete Response Letter for Immunotherapy

Patients with severe frostbite who were administered Aurlumyn monotherapy experienced a significantly reduced risk of the need for amputation.

Aurlumyn Gets First FDA Approval for a Severe Frostbite Medication 

Augtyro was previously approved in November 2023 to treat locally advanced or metastatic ROS1-positive non-small cell lung cancer.

FDA Grants Priority Review to Augtyro for NTRK-Positive Solid Tumors

Onivyde (irinotecan liposome injection) in combination with oxaliplatin, fluorouracil, and leucovorin (NALIRIFOX) was found to improve overall survival in metastatic pancreatic adenocarcinoma.

Ipsen Nabs FDA Approval for NALIRIFOX in First-Line Metastatic Pancreatic Adenocarcinoma 

Examination evaluates investigational stem cell interventions, including how the states have implemented their own policies when it comes to their uses. 

Analyzing State-Based Legislation Surrounding Medical Freedom, Stem Cell Procedures 

BXCL701 combined with Keytruda (pembrolizumab) is being evaluated for patients with metastatic castration-resistant prostate cancer with small cell neuroendocrine and adenocarcinoma phenotypes.

FDA Fast Tracks Novel Treatment for Metastatic Small Cell Neuroendocrine Prostate Cancer

In clinical trials, bepirovirsen was found to recognize the RNA used by hepatitis B virus to replicate in infected liver cells.

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