July 25th 2024
A single dose of giroctocogene fitelparvovec significantly reduced the mean total annual bleeding rate in patients with moderately severe to severe hemophilia A.
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.
FDA Approves Keytruda Plus Chemotherapy for Biliary Tract Cancer
November 1st 2023The approval of pembrolizumab (Keytruda; Merck) combined with gemcitabine and cisplatin for the treatment locally advanced unresectable or metastatic biliary tract cancer is the sixth sixth indication for the anti-PD-1 therapy for gastrointestinal cancers.
What Pharma Fears Most About AI
October 4th 2023In this Q&A with Pharmaceutical Executive®, Andrew Hopkins, founder and CEO of Exscientia, reveals how artificial intelligence (AI) is currently being utilized in the pharma industry, predictions for where AI can be implemented in the future, and what pharma fears most about AI.