Regulatory
PDC*line is a potent, scalable and versatile professional antigen-presenting T-cell with great potential for treating a range of cancers
Strong Crysvita® (burosumab) Launch Continues with Approximately 730 Patients on Reimbursed Commercial Therapy in the United States
On March 27, the U.S. Food and Drug Administration (FDA) approved Novartis’ Mayzent (isiponimod) for adults with relapsing types of multiple sclerosis.
The Jacobus LEMS Drug was approved for pediatric patients. However, the approval was based on results from a study of adult patients, which means that doctors could opt to prescribe this medication for adult LEMS patients.
Invitrocue Limited is pleased to provide its Appendix 4C cash flow statement for the quarter ended March 31, 2019 and to announce the appointment of Dr Sharifuddin Abdul Wahab as Global Insurance Advisor.
Bempedoic Acid is an Oral, Once-daily ATP Citrate Lyase (ACL) Inhibitor that Reduces Cholesterol and Fatty Acid Synthesis in the Liver
The FDA rapidly reviewed and approved the medication under the FDA’s Real-Time Oncology Review (RTOR) and Assessment Aid pilot program.
The approval is a first for the the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM). The drug has a list price of $225,000.
SMA is a severe neuromuscular disease caused by a mutation in the SMN1 gene, which codes for SMN, a protein necessary for motor neuron function.
Curbing the opioid crisis will continue to be a key focus for the FDA. Ned Sharpless talked about new packaging rules that are expected to help stem the concerns about too many opioids on the streets.
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