CLINICAL ROLE -
FDA Accepts sNDA of Roflumilast Foam for Scalp and Body Psoriasis
The FDA assigned a Prescription Drug User Fee Act action date of May 22, 2025.
FDA Accepts New Drug Application for Delgocitinib Cream to Treat Chronic Hand Eczema
If approved, delgocitinib cream would be the first US treatment indicated for moderate to severe chronic hand eczema.
FDA Grants Bimekizumab-Bkzx Approval for Treatment of Chronic Immune-Mediated Inflammatory Diseases
Approved with 3 new indications, bimekizumab-bkzx is the first and only interleukin-17 inhibitor approved for these diseases.
FDA Approves Isatuximab With Bortezomib, Lenalidomide, and Dexamethasone for NDMM
The decision expands treatment options for patients with transplant-ineligible newly diagnosed multiple myeloma (NDMM).
Arimoclomol Becomes First FDA Approved Treatment for Neimann-Pick Disease Type C
The rare disease can result in progressive neurological symptoms and organ complications.
FDA Approves Amivantamab-vmjw for NSCLC With EGFR Exon 19 Deletions or L858R Mutations
Amivatamab-vmjw is a fully-human bispecific antibody targeting EGFR and MET with immune cell-directed activity.
FDA Grants Fast Track Designation to ICT01 in Combination With Azacitidine and Venetoclax for Acute Myeloid Leukemia
The humanized anti-butyrophilin 3A monoclonal antibody selectively activates Vγ9Vδ2 T-cells.
FDA Approves Pembrolizumab Plus Pemetrexed and Platinum Chemotherapy for Malignant Pleural Mesothelioma
The approval is based on positive results from the phase 2/3 IND.227/KEYNOTE-483 trial.
FDA Approves Benralizumab for Eosinophilic Granulomatosis With Polyangiitis
Eosinophilic granulomatosis with polyangiitis is a rare and immune-mediate vasculitis that can damage multiple organs and be fatal if left untreated.
FDA Approves Ribociclib in Combination With an Aromatase Inhibitor for HR+/HER2- Early Breast Cancer
The treatment significantly reduced risk of occurrence by 25% compared with endocrine therapy alone.
FDA Grants MM-II Fast Track Designation for Treatment of Osteoarthritis Knee Pain
The non-opioid drug can induce healing of joint cartilage in patients with osteoarthritis.
FDA Approves Lebrikizumab for Treatment of Atopic Dermatitis
Lebrikizumab (Ebglyss; Eli and Lilly Company) is a monthly maintenance injection with proven efficacy in adults and children aged 12 to 18 years.
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.
