CLINICAL ROLE -
FDA Gives Priority Review to Vusolimogene Oderparepvec for Melanoma
Vusolimogene oderparepvec in combination with nivolumab is being assessed to treat individuals with unresectable or metastatic stage IIIb-IV cutaneous melanoma.
Leqselvi from Sun Pharmaceutical Industries
Managing Cancer Treatment Amid a Nationwide IV Fluid Shortage
The closure of Baxter’s North Cove facility has significantly impacted existing IV fluid shortages into 2025.
FDA’s Accelerated Approval Pathway Under Scrutiny for Key Drug Approvals
The report from the Office of Inspector General highlights inconsistencies, lack of transparency, and the need for stronger safeguards.
FDA Approves Dato-DXd for Adults With Unresectable or Metastatic HR+, HER2- Breast Cancer
Compared with chemotherapy, Dato-DXd demonstrates favorable median progression-free survival and overall survival in a phase 3 clinical trial.
FDA Targets Nicotine to Reduce Lung Cancer and Other Tobacco-Related Diseases
The FDA proposes to cap the nicotine level at 0.7 mg per gram of tobacco in cigarettes and certain other combusted tobacco products.
FDA Proposes Front-of-Package Nutrition Label for Most Packaged Foods
If finalized, the requirement would include readily available nutrition information, including saturated fat, sodium, and added sugar content.
The FDA Approves Sotorasib With Panitumumab for Treatment of Patients with KRAS G12C-Mutated Metastatic Colorectal Cancer
Data from the CodeBreaK 300 trial supported the FDA's approval.
FDA Approves Acalabrutinib With Bendamustine, Rituximab For Patients With Previously Untreated Mantle Cell Lymphoma
Acalabrutinib with bendamustine and rituximab shows efficacy in patients with untreated mantel cell lymphoma by increasing progression-free survival in the ECHO trial.
FDA Approves Axatilimab-csfr 9 mg and 22 mg Vial Sizes for cGVHD
The current approved dose of axatilimab-csfr is 0.3 mg/kg up to a maximum dose of 35 mg and will be administered as an intravenous infusion over 30 minutes every 2 weeks.
FDA Approves Mirikizumab-Mrkz to Treat Adult Patients With Crohn Disease
This is mirikizumab’s second FDA-approved indication in inflammatory bowel disease.
FDA Grants Breakthrough Device Designation to pTau 217 Blood Test for Alzheimer Disease Detection
The test meets a critical unmet need for patients with Alzheimer disease who have not yet been undiagnosed.
FDA Bans Red Dye No. 3 in Food and Drugs, Citing Cancer Risks
Studies shows that Red Dye No. 3 was associated with tumor growth in male rats.
BBO-850 Receives Fast Track Designation for NSCLC Treatment
According to the investigators, BBO-8520 represents a first-in-class approach to treating patients with previously treated KRASG12C-mutated metastatic non-small cell lung cancer (NSCLC).
FDA Grants Additional Fast Track Designation to Emiltatug Ledadotin to Treat HER2 Low, HER2-Negative Breast Cancer
A new indication for the antibody-drug conjugate expands the future clinical potential of the treatment in patients with the rare breast cancer.
FDA Grants Datopotamab Deruxtecan Priority Review for EGFR-Mutated NSCLC
Datopotamab deruxtecan was also granted breakthrough therapy designation in December 2024.
FDA Grants Priority Review to Nipocalimab as Potential Treatment of Generalized Myasthenia Gravis
If approved, nipocalimab can treat antibody positive individuals with generalized myasthenia gravis.
FDA Grants Breakthrough Therapy Designation to GSK’227 to Treat Osteosarcoma
The designation was supported by data from the phase 2, open-label, randomized, multi-center ARTEMIS-002 clinical trial, which assessed the safety and efficacy of GSK’227.
FDA Grants Fast Trask Designation to Invikafusp Alfa for Advanced Colorectal Cancer
Invikafusp alfa (STAR0602; Marengo Therapeutics Inc) is being investigated as a treatment for advanced colorectal cancer with high tumor mutational burden.
FDA Grants Orphan Drug Designation to CNP-104 for Primary Biliary Cholangitis
The designation follows positive phase 2a trial results (NCT05104853) presented at the 2024 AASLD The Liver Meeting.
FDA Grants ALG-801 Orphan Drug Designation for Treatment of Pulmonary Arterial Hypertension
ALG-801 could present new opportunities to improve treatment and management of patients with pulmonary arterial hypertension, a life-threatening condition.
Abenacianine Injection Receives FDA Fast Track Designation, Helps Visualize Tumors During Surgery
In a phase 2 trial (NCT05400226), abenacianine helps surgeons visualize tumors in lung during surgery and is safe and well-tolerated in patients.
FDA Announces Priority Review for CUTX-101 to Treat Menkes Disease
These new regulatory developments put CUTX-101 on track to become the first FDA-approved treatment for patients with Menkes disease.
Deramiocel Shows Promise in Addressing Heart Failure in Duchenne Muscular Dystrophy
Duchenne muscular dystrophy is an incurable neuromuscular disorder that can lead to cardiomyopathy, resulting in heart failure.
FDA Grants Amezalpat Orphan Drug Designation for Treatment of Hepatocellular Carcinoma
The new designation for the selective PPAR⍺ antagonist follows positive phase 1b/2 clinical trial results.
FDA Grants Breakthrough Therapy Designation to Tividenofusp Alfa for Treatment of Hunter Syndrome
Regulatory action could help patients with Hunter syndrome who have cognitive and behavioral complications and often do not have an effective treatment crossing the blood-brain barrier.
Posdinemab Receives FDA Fast Track Designation for Treatment of Alzheimer Disease
As an investigational monoclonal antibody, posdinemab targets the mid-domain of AD-specific phosphorylated tau.
FDA Grants Sunvozertinib Priority Review for Treatment of Non-Small Cell Lung Cancer With EGFR exon20ins Mutations
Sunvozertinib was originally approved in China, making it the world’s first and only oral treatment for these patients.
Prucalopride Tablets for Chronic Idiopathic Constipation Launches, Approved for 180-Day CGT Designation
The tablets are indicated for treatment of adults with chronic idiopathic constipation, with further research needed to assess efficacy and safety in children.
Avutometinib Plus Defactinib Moves One Step Closer to Approval for Treatment of Ovarian Cancer
If approved, the combination of avutometinib with defactinib could be the first FDA-approved treatment option for low-grade serous ovarian cancer.
