Brand & Product Security

Articles

The FDA has assigned Servier’s New Drug Application for vorasidenib to treat IDH-mutant gliomas with a Prescription Drug User Fee Act action date of August 20, 2024.

FDA Accepts, Grants Priority Review to NDA for Vorasidenib in IDH-Mutant Gliomas

FDA accepts Bristol Myers Squibb's application for Krazati (adagrasib) plus cetuximab for patients who received prior treatment for KRASG12C-mutated locally advanced or metastatic colorectal cancer.

Krazati Combination for Advanced, Metastatic Colorectal Cancer Granted FDA Priority Review

Tagrisso (osimertinib) approved for use in combination with platinum-based chemotherapy in adults with locally advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer harboring EGFR exon 19 deletions or exon 21 L858R mutations.

FDA Approves Tagrisso With Chemotherapy for EGFR-Mutated Advanced Lung Cancer

Iovance’s Amtagvi (lifileucel) gains FDA accelerated approval for adults with unresectable or metastatic melanoma.

FDA Approves First One-Time, Individualized T Cell Therapy for a Solid Tumor

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.

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