CLINICAL ROLE -
FDA Grants Inavolisib Priority Review for Treatment of PIK3CA-Mutated Breast Cancer
The priority review of inavolisib is for treatment of patients with advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation.
FDA Approves mRNA-1345 for Protection Against Lower Respiratory Tract Disease Caused by RSV
This is Moderna's second mRNA vaccine approval and the first mRNA vaccine approved for an indication other than COVID-19.
FDA Approves Deutetrabenazine Once-Daily Extended-Release Tablets to Treat TD and HD Chorea
The treatment is indicated for adult patients with tardive dyskinesia and Huntington disease chorea, with tablets now available in 4 different doses.
FDA Grants Priority Review for Zanidatamab to Treat HER2-Positive Metastatic Biliary Tract Cancer
If approved, zanidatamab will be the first HER2-targeted treatment indicated for individuals with this type of biliary tract cancer.
FDA Approves Clonidine Hydrochloride For Treatment of ADHD in Pediatric Patients
The treatment is the first liquid non-stimulant for attention deficit hyperactivity disorder to be approved in the United States.
FDA Accepts Isatuximab for Priority Review for Treatment of Transplant-Ineligible Multiple Myeloma
Isatuximab is used in combination with bortezomib, lenalidomide, and dexamethanose.
Proposed FDA Rule Could Limit Pharmacy Compounding
Under the proposal, specific drugs would be prohibited
FDA Grants Tina-qant Lp(a) Assay Breakthrough Device Designation
A lipoprotein (a) (Lp[a]) assay has been granted breakthrough device designation to expand identification of patients with elevated Lp(a) and genetic predispositions to cardiovascular disease.
FDA Grants Breakthrough Therapy Designation to Inavolisib for PIK3CA-Mutated Breast Cancer
Inavolisib was submitted to the FDA for review as a first-line treatment for advanced HR-positive, HER2-negative PIK3CA-mutated breast cancer.
FDA Grants Breakthrough Therapy Designation for Larsucosterol in Alcohol-Associated Hepatitis
The primary outcome was a 90-day incidence of mortality or liver transplant for individuals who received larsucosterol, compared to the placebo group.
FDA Approves First Biosimilars to Eylea
Aflibercept-jbvf (Yesafili; Biocon Biologics) and aflibercept-yszy (Opuviz; Biogen, Samsung Bioepis) are the first interchangeable biosimilars to aflibercept (Eylea; Regeneron).
FDA Approves Subcutaneous Belimumab for Patients Aged 5 With Systemic Lupus Erythematosus
Belimumab (Benlysta; GSK) is a B-lymphocyte stimulator-specific inhibiting monoclonal antibody.
The FDA Grants Accelerated Approval to Tarlatamab-dlle in Small Cell Lung Cancer
Tarlatamab is a first-in-class immunotherapy that binds to DLL3 tumor cells and CD3 T-cells, to kill DLL3-expressing SCLC.
FDA Grants Accelerated Approval for Liso-Cel in Patients With Relapsed or Refractory Follicular Lymphoma
The indication is for adult patients who have received at least 2 prior lines of systemic therapy and is based on the response rate and duration of response shown in a phase 2 trial.
FDA Grants Fast Track Designation for SNB-101 to Treat Small Cell Lung Cancer
SNB-101 is the first nanoparticle anticancer drug that was developed exceedingly insoluble SN-38 into polymer nanoparticles.
FDA Approves Updated Label for Altuviiio to include Full Data on Pediatric Patients With Hemophilia A
Antihemophilic factor (recombinant) Fc-VWF-XTEN fusion protein-ehtl was initally approved in February 2023 for adults and children with hemophilia A for prophylaxis and on-demand treatment to control bleeding.
FDA Approves sBLA for Adalimumab-adaz as Interchangeable Biosimilar for Humira
A provisional determination is also provided for the 40 mg/0.4 mL strength due to remaining interchangeability designation for another biosimilar to Humira.
FDA Approves WGc-043, EB Virus-Related mRNA Therapeutic Cancer Vaccine for Use in Clinical Trials
This is the first approval of an EB virus-related mRNA therapeutic cancer vaccine and is a landmark achievement in future research on cancer treatment.
Commercializing CRISPR/Cas9 Therapy: FDA Approval of Exa-Cel Marks Milestone in Treatment Development
These developments highlight the dynamic landscape of health care innovation and the collaborative efforts driving progress in disease management and treatment.
FDA Grants 510(k) Clearance for Rika Plasma Donation System
The Rika system uses an individualized nomogram to help determine the plasma collection volume that is needed for each individual donor.
FDA Committee to Review Data Supporting New Drug Application for MDMA for PTSD in June
This is the first FDA advisory committee meeting that will review a potential new posttraumatic stress disorder treatment in 25 years.
FDA Accepts Biologics License Application for Subcutaneous Formulation of Nivolumab
The new administration method, which is co-formulated with rHuPH20, is usable in previous approved nivolumab indications for solid tumors in adult patients.
FDA Grants Fast Track Designation to Eneboparatide for Treatment of Patients With Hypoparathyroidism
Currently, the treatment is being evaluated in the phase 3 CALYPSO study to further prove the safety and efficacy in patients with hypoparathyroidism.
FDA Approves High-Concentration, Citrate-Free Cyltezo for the Treatment of Chronic Inflammatory Diseases
This citrate-free and high-dose approval of the biosimilar Humira provides another option to treat patients who are living with various inflammatory diseases.
FDA Approves Fidanacogene Elaparvovec-dzkt as One-Time Gene Therapy for Adults With Hemophilia B
The 1-time treatment may be a better alternative for patients who don’t want to undergo frequent doses of standard of care intravenous factor IX infusions.
FDA Grants Full Approval to Tisotumab Vedotin-tftv for Recurrent, Metastatic Cervical Cancer
Tisotumab vedotin-tftv is the first antibody-drug conjugate to demonstrate positive overall survival data in patients with previously treated recurrent or metastatic cancer.
FDA Approves Trastuzumab Biosimilar to Treat Forms of HER2-Overexpressing Cancer
Trastuzumab is indicated for adjuvant breast cancer, metastatic breast cancer, and gastric cancer.
FDA Accepts Supplemental New Drug Application for Tapinarof Cream, 1%, in Atopic Dermatitis
The acceptance is based on positive data from the phase 3 ADORING 1 and ADORING 2 pivotal trials, as well as interim results from the phase 3 ADORING 3 open-label, long-term extension trial.
FDA Approves Mavorixafor Capsules to Treat Patients With WHIM Syndrome
The indication is for patients aged 12 years of age and older, and the treatment is intended to increase the number of mature neutrophils and lymphocytes in patients.
FDA Grants Accelerated Approval to Tovorafenib for Pediatric Patients With BRAF-Mutated LGG
Tovorafenib is the first systemic therapy to be approved for the treatment of pediatric patients who have low-grade glioma with BRAF rearrangements or fusions.
