Regeneron secures expanded FDA nod for Evkeeza to include young children
The FDA approval extends Evkeeza’s indication to include children aged five to 11 years with homozygous familial hypercholesterolemia…
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23 Mar 23
The FDA approval extends Evkeeza’s indication to include children aged five to 11 years with homozygous familial hypercholesterolemia…
17 Mar 23
The FDA approval is based on results from the Phase 2/3 TADPOLE clinical trial, in which the combination…
15 Mar 23
The Pfizer-BioNTech bivalent Covid-19 vaccine single booster dose is authorised for children as young as six months to…
13 Mar 23
Zavzpret is a small molecule calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray, indicated for the acute treatment…
08 Mar 23
The CNP analog already has FDA approval in paediatric patients with achondroplasia who are aged five years old…
06 Mar 23
The EC approval was based on results from Phase 2 BEYOND study and allows BMS to commercialise Reblozyl…
01 Mar 23
SKYCLARYS is an oral, once-daily medication, indicated for the treatment of Friedreich’s ataxia, an ultra-rare, inherited neurodegenerative disorder,…
27 Feb 23
China’s NMPA approval is based on results from the DESTINY-Breast03 clinical trial, in which Enhertu showed a 72%…
17 Feb 23
Lamzede is the first and only enzyme replacement therapy intended for the treatment of non-central nervous system manifestations…
14 Feb 23
The IND clearance by the FDA paves the way for the Dutch clinical-stage company to assess the safety…