Follicular Lymphoma Drug Co-Developed by AbbVie and Genmab Gets FDA Breakthrough Designation
November 27th 2023AbbVie and Genmab will share commercial responsibilities in the United States and Japan for epcoritamab-bysp (Epkinly), whereas AbbVie will be responsible for further global commercialization.
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.