CLINICAL ROLE -
Atezolizumab and Hyaluronidase-tqjs Subcutaneous Formulation Receives FDA Approval to Treat Multiple Forms of Cancer
Subcutaneous administration of atezolizumab and hyaluronidase-tqjs had similar efficacy to intravenous administration.
FDA Approves Guselkumab for Treatment of Ulcerative Colitis
Guselkumab (Tremfya; Johnson & Johnson) is the first and only approved fully human and dual-acting monoclonal antibody blocking interleukin-23 and binding to CD64 receptors.
FDA Grants Breakthrough Therapy Designation to Plozasiran for Familial Chylomicronemia Syndrome
FCS is a severe, rare genetic disease in which patients have extremely high triglyceride levels, typically above 880 mg/dL.
FDA Grants Rare Pediatric Disease Designation to NS-050/NCNP-03 to Treat Muscle Wasting Disease
NS-050/NCNP-03 is being developed to aid individuals with confirmed gene mutations that are treatable with exon 50 skipping therapy.
FDA Approves Sparsentan, With Data Indicating Slowing of Kidney Function Decline in IgA Nephropathy
Full traditional approval follows accelerated approval of the medication last year.
FDA Grants Breakthrough Therapy Designation to Sanbexin for Acute Ischemic Stroke
Edaravone and dexborneol sublingual tablets are an innovative first drug to be designed for treatment of stroke and granted this designation.
FDA Grants Orphan Drug Designation for ABD-147 for Neuroendocrine Carcinoma
Previously, the FDA granted fast track designation to ABD-147 (Abdera Therapeutics Inc) for extensive stage small cell lung cancer.
FDA Grants Regenerative Medicine Advanced Therapy Designation for OBX-115
OBX-115 could offer further treatment options for individuals with advanced or metastatic melanoma by enhancing persistence, antitumor activity, and clinical safety of TIL cell therapy.
FDA Approves Diagnostics for Olaparib, Abiraterone Combination Therapy in Patients With BRCA-Mutated mCRPC
These companion diagnostics are poised to provide simpler and detailed insights into a patient’s genomic alternations, which could improve outcomes for patients with prostate cancer.
FDA Authorizes New Drug Application For Trial to Evaluate Treatment for Long COVID
Bezisterim, an anti-inflammatory insulin sensitizer, will be authorized to proceed to a phase 2 clinical trial.
FDA Grants Priory Review for Mirdametinib to Treat NF1-PN
Mirdametinib is an oral, allosteric small molecule MEK inhibitor to treat pediatric patients with neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN).
FDA Clears Omnipod 5 Automated Insulin Delivery System for Use in Adults With Type 2 Diabetes
Previously, the device was indicated for the management of type 1 diabetes in patients aged 2 years and older.
FDA Approves True Sight Oncology Comprehensive Test to Identify NTRK Solid Tumors
With diagnostic tools, oncology pharmacists and other health care providers can help to identify treatments that have the best probability of working for a specific patient.
FDA Grants Fast Track Designation to BGB-16673 for Patients With R/R CLL/SLL
The indication is for adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who were treated with at least 2 prior lines of therapy.
FDA Grants Fast Track Designation to 64Cu-SAR-bisPSMA for Prostate Cancer Diagnosis
The proposed diagnostic agent has a long half-life, enables imaging the next day, and correlates to a longer shelf life in the pharmacy.
Updated COVID-19 Vaccines Approved by FDA to Defend Against Circulating Variants
The acceptance will lead to vaccines that provide better protection against the KP.2 strain of SARS-CoV-2.
FDA Accepts Biologics License Application For Nivolumab Plus Ipilimumab to Treat Hepatocellular Carcinoma
The FDA assigned the combination a Prescription Drug User Fee Act goal date of April 21, 2025.
IMPT-514 Receives Investigational New Drug Clearance From the FDA
The bispecific CAR T-cell therapy for treatment of multiple sclerosis is the first to target both CD19 and CD20.
GSK5764227 Receives Breakthrough Therapy Designation to Treat Extensive-Stage Small–Cell Lung Cancer
The breakthrough therapy designation was granted based on ongoing data from the ARTEMIS-001 phase 1 open-label, multi-center trial.
Propofol Injectable Emulsion Single-Dose Vials Receive FDA Approval
Propofol has a history of chronic shortage due to supply chain constraints.
FDA Accepts NDA and Priority Review Application for Vimseltinib in Tenosynovial Giant Cell Tumors
Vimseltinib (Deciphera Pharmaceuticals) has a Prescription Drug User Fee Act goal date of February 17, 2025.
FDA Approves Amivantamab-Vmjw and Lazertinib for First-Line Treatment of NSCLC
The combination is the first and only multi-targeted chemotherapy-free regimen that demonstrated superiority compared with osimertinib for non–small cell lung cancer (NSCLC).
AR882 Receives Fast Track Designation From the FDA for Treatment of Clinically Visible Tophaceous Gout
The highly potent, selective URAT1 inhibitor may help reduce serum uric acid levels and treat clinically visible tophi.
FDA Grants Breakthrough Therapy Designation to DS-8201a and T-DXd to Treat Metastatic Breast Cancer
Fam-trastuzumab deruxtecan-nxki has received 4 breakthrough therapy designations, including the latest approval.
FDA Grants Orphan Drug Designation to PT217 for Neuroendocrine Carcinoma
Currently, the drug will be studied in the SKYBRIDGE (NCT05652686) trial, a first-in-human, phase 1/2, open-label, dose-escalation and expansion study.
First At-Home Syphilis Test Receives Marketing Authorization From the FDA
The OTC antibody test can detect current or past infection but should be followed by additional testing to confirm diagnosis.
FDA Grants 510(k) Clearance for Traumagel to Control Bleeding
The hemostatic gel is plant-based and designed to stop and control bleeding within seconds after applied to wound at the point of care.
Durvalumab Receives FDA Approval for Treatment of Non-Small Cell Lung Cancer
Durvalumab is a human monoclonal antibody that targets and binds to PD-L1 to interrupt tumor immune-evasion tactics.
FDA Grants Priority Review for Durvalumab to Treat Small Cell Lung Cancer
The supplemental biologics license application was granted based on results from the ADRIATIC phase 3 trial among individuals with limited stage small cell lung cancer.
FDA Grants Fast Track Designation for KB-GDT-01 to Treat Patients with Non-Small Cell Lung Cancer
The decision is based positive data from the Deltacel-01 clinical trial.
