December 4th 2024
Results from the SURMOUNT-5 Phase IIIb trial found that Zepbound achieved an average weight loss of 20.2%, surpassing Wegovy’s 13.7%.
FDA Approves Keytruda Plus Chemotherapy for Gastric, Gastroesophageal Junction Adenocarcinoma
November 17th 2023Merck's pembrolizumab (Keytruda) plus fluoropyrimidine- and platinum-containing chemotherapy approved for the first-line treatment of patients with locally advanced unresectable or metastatic, HER2-negative gastric/GEJ adenocarcinoma.
FDA Approves Truqap Plus Faslodex for Advanced HR-Positive Breast Cancer
November 17th 2023Capivasertib (Truqap) plus fulvestrant (Faslodex) is a first-of-its-kind combination for HR-positive, HER2-negative locally advanced or metastatic breast cancer with one or more PIK3CA, AKT1 or PTEN biomarker alterations.
FDA Approves CorMedix Inc’s Treatment for Bloodstream Infections in Patients Receiving Dialysis
November 15th 2023Defencath is indicated for the prevention and treatment of catheter-related bloodstream infections in adults with kidney failure administered chronic hemodialysis via a central venous catheter.
FDA Approves Expanded Nerve Block Indications for Pacira BioSciences' Exparel
November 13th 2023FDA expands indications for bupivacaine liposome injectable suspension (Exparel; Pacira BioSciences, Inc.) for use in adult patients as an adductor canal block and a sciatic nerve block in the popliteal fossa.
FDA Grants Priority Review to Expand Indication for Bristol Myers Squibb’s Breyanzi in CLL, SLL
November 10th 2023Supplemental Biologics License Application for lisocabtagene maraleucel (Breyanzi) seeks to expand the current indication include the treatment of adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who were previously treated with a BTKi and BCL2i.
FDA Approves Expanded Indication for Abatacept to Treat Juvenile Psoriatic Arthritis
November 1st 2023Abatacept is indicated across multiple inflammatory conditions, including for the treatment of adult patients with moderately to severely active rheumatoid arthritis, pediatric patients with moderately to severely active polyarticular juvenile idiopathic arthritis, and active juvenile psoriatic arthritis.
FDA Approves Interchangeable Ustekinumab Biosimilar for Inflammatory Diseases
November 1st 2023The FDA granted Wezlana with interchangeable designation after clinical trials found no clinically significant differences in safety and efficacy for the indicated conditions across multiple inflammatory diseases.