Regulatory
Moderna reported positive interim results from the Phase II/III KidCOVE trial of its mRNA COVID-19 vaccine for children six months to under two years and two to six years of age.
Takeda faces yet another setback by the U.S. Food and Drug Administration for its parathyroid hormone, natpara.
An FDA Investigational New Drug application has been approved for NeuroSense Therapeutics Ltd.’s PrimeC, a potential therapeutic targeting amyotrophic lateral sclerosis (ALS).
Provention Bio has announced that the FDA has accepted its biologics license application resubmission for teplizumab, a drug intended to delay clinical Type I Diabetes (T1D) in at-risk individuals.
BMS achieved a monumental milestone when the U.S. Food and Drug Administration approved Opdualag (nivolumab and relatlimab-rmbw) for the treatment of melanoma.
Sir Mene Pangalos said the company was considering not submitting it to the FDA if it finds it is “banging its head against a brick wall indefinitely.”
Tetra Bio-Pharma announced that its investigational new drug involving cannabinoids, QIXLEEF, received guidance to strengthen its nonclinical and toxicological data from the FDA.
There is some evidence that COVID-19 infection might be linked to an increase in diabetes, particularly Type 1 diabetes, which is an autoimmune disease most commonly diagnosed in children.
After reviewing the trial’s Independent Data Monitoring Committee, the EMPA-KIDNEY trial announced it would stop early as it met prespecified criteria for positive efficacy.
Several biopharma companies celebrate the U.S. Food and Drug Administration’s approval for clinical trials involving therapeutics for cancer treatment.
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