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.
Concerns Raised Over False Claims in Direct-to-Consumer Online Marketing of Ketamine
November 8th 2023The online promotion of intravenous infusions and oral forms of subanesthetic ketamine for the treatment of mental health conditions has been found to frequently carry misleading or false information.
Sanofi Issues Update on Shortages of Beyfortus for Respiratory Syncytial Virus
November 7th 2023Due to a higher than anticipated demand, Sanofi is carefully managing distribution of 50 mg doses of Beyfortus in the private market to fulfill existing orders and provide equitable access to remaining doses for the vaccine that protects infants against respiratory syncytial virus.