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Checkpoint Therapeutics announced that its checkpoint inhibitor cosibelimab is showing positive objective response rate data in patients with locally advanced cutaneous squamous cell carcinoma.
Moderna’s study, dubbed BabyCove, is expected to begin recruiting in September and will include up to 700 babies three to six months of age.
Covis announced that the U.S. Food and Drug Administration has granted the company a hearing for its controversial drug Makena, which is intended to reduce preterm births.
Biogen has terminated its asset purchase agreement with Karyopharm Therapeutics, putting a halt to the development of KPT-350 (BIIB100), which was being evaluated as a treatment for ALS.
An FDA advisory committee voted Wednesday to recommend both the Pfizer-BioNTech and Moderna COVID-19 vaccines for children as young as six months old.
Shares of Acadia are up more than 12% in early trading after the FDA published briefing documents related to its supplemental NDA for antipsychotic therapeutic.
A recent study found that over a span of ten years, the FDA approved cancer drugs approximately eight months earlier than the same drugs were greenlit by the European Commission (EC).
Jazz Pharmaceuticals, Redx Pharma and Omega Therapeutics are pushing forward with their cancer treatments with Investigational New Drug approval and IND application submission.
In a unanimous vote, a panel of FDA advisors voted to recommend the approval of Moderna’s COVID-19 vaccine for children between the ages of six and 17 years old.
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