SPOTLIGHT -
In an interview with Pharmaceutical Executive associate editor Don Tracy, Ashley Gaines, VP, head of breast cancer franchise, discusses newly approved Truqap.
FDA Approves High Concentration, Citrate-Free Version of Cyltezo, Boehringer Ingelheim’s Humira Biosimilar for Chronic Inflammatory Diseases
New formulation of Cyltezo aims to complement the existing low-concentration formulation and offer more treatment options for various chronic inflammatory diseases.
FTC Ramps Up Efforts to Crackdown on Inaccurate Patent Listings in the FDA’s Orange Book
The move targets over 300 listings for 20 branded products from companies such as AstraZeneca, Novo Nordisk, and GSK that the agency said inhibits the generic drug market.
FDA Approves Abbott’s Dissolving Stent System for Chronic Limb-Threatening Ischemia in Arteries Below the Knee
Treatment marks the first dissolving stent approved in the United States for treating chronic limb-threatening ischemia in arteries below the knee.
FDA Grants Full Approval to Tivdak for Treating Recurrent or Metastatic Cervical Cancer Patients Experiencing Disease Progression After Chemotherapy
Approval of Tivdak was based on promising results from a Phase III innovaTV 301 clinical trial, which demonstrated a 30% reduction in the risk of death in patients with recurrent or metastatic cervical cancer.
FDA Approves Aquestive Therapeutics’ Libervant for the Treatment of Seizure Clusters in Children Aged 2 to 5 Years
Approval of Libervant marks the first orally administered rescue medication for this age group to be cleared by the FDA for epilepsy.
FDA Approves New Herceptin Biosimilar for the Treatment of Multiple HER2-Overexpressing Cancers
Hercessi marks Accord BioPharma’s first biosimilar to be approved in the United States, with multiple indications for HER2-overexpressing breast and gastric cancers.