FDA
The FDA issued a rare Refusal-to-File letter to Moderna over its mRNA-based influenza vaccine application, in an unusual move that sent the biotech’s shares tumbling.
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The Senate failed to pass a massive spending bill on Thursday—which includes the rare pediatric PRV program but also funding for the Immigration and Customs Enforcement’s large-scale crackdown in Minnesota and other states.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
Together with robust data-driven modeling, rethinking regulation and data use could push forward a notoriously challenging field.
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In 2021, Sanofi earned about $4.2 billion from Dupixent sales, and Regeneron earned about $1.8 billion.
Johnson & Johnson’s partner, Legend Biotech, has been awarded FDA approval for its (CAR-T) therapy, Carvykti, for the treatment of multiple myeloma disease.
The FDA declined approval for Amryt Pharma’s therapeutic oleogel-S10. The topical gel is intended to treat a group of rare skin diseases called epidermolysis bullosa.
The FDA lifts its clinical hold on Ocugen’s COVID-19 vaccine, and Ocugen announces a clinical trial for the treatment of inherited retinal diseases.
The latest EUA adjustment was based on findings that Evusheld might not be as active against certain subvariants of Omicron, but it could be if the dosage is increased.
Eli Lilly’s Jardiance scores expanded heart failure approval from the FDA and will now be available to all patients with heart failure to reduce the risk of death and hospitalization.
The FDA’s decision to approve Purdue’s drug Nalmefene earned mixed reactions, especially as the company is in the middle of lawsuits. Here’s what you need to know.
With IND approval, the therapeutics have become the first LBPs for Parkinson’s disease cleared by the FDA.
A new packaging and labeling manufacturing facility has derailed the potential approval of Malinckrodt’s investigational hepatorenal syndrome (HRS) treatment, terlipressin.
The end of February picks up significantly from early this year for the U.S. Food and Drug Administration and its PDUFA dates.