MPR16h
FDA Drug Approval Decisions Expected in May 2025
The FDA is expected to decide on treatments for COPD, psoriasis, rare neuroendocrine tumors, and a next-generation COVID-19 vaccine.
FDA delays full approval of Novavax Covid-19 vaccine even though it was on track for clearance
The US Food and Drug Administration has delayed granting full approval of Novavax’s Covid-19 vaccine despite it being on ...
STAT7d
Wave to submit Duchenne drug for approval after Phase 2 success
Wave Life Sciences’ experimental treatment for Duchenne muscular dystrophy hit the mark in a mid-stage study, setting the ...
BioPharma Dive7d
Wave to seek approval of Duchenne drug after mid-stage study data
The company plans to file next year for an accelerated clearance of its "exon-skipping" treatment, which would compete with one of Sarepta's medicines.
Wave Life Sciences to submit Duchenne drug for approval after Phase 2 success
The Cambridge-based biotech's experimental treatment for Duchenne muscular dystrophy hit the mark in a mid-stage study, ...