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Regulatory Intelligence & Drug Approvals4 weeks agoSTAT+: In Duchenne muscular dystrophy, a promising therapy is available to a fortunate few
Exon-skipping drugs present a critical test for the FDA’s goal of encouraging treatments for rare disease.
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Regulatory Intelligence & Drug Approvals4 weeks agoPfizer’s Tukysa Regimen Receives FDA Approval as Front-Line Maintenance Treatment for HER2+ Metastatic Breast Cancer
NEW YORK--(BUSINESS WIRE) October 7, 2026 -- Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved Tukysa (tucatinib) in...
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Regulatory Intelligence & Drug Approvals4 weeks agoClick claims FDA okay for first-in-class schizophrenia DTx
Click Therapeutics has won the first-ever FDA approval for a treatment for the negative symptoms of schizophrenia, a DTx called Motivista.
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Regulatory Intelligence & Drug Approvals4 weeks agoFDA extends review of Novo’s hemophilia A drug, citing manufacturing issues
Despite the regulatory delay, Novo is still expecting a 2027 launch for its hemophilia A drug denecimig.
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Regulatory Intelligence & Drug Approvals4 weeks agoOrganiCare, LLC / OrganiCare Nature’s Science, LLC – 734925 – 10/01/2026
Unapproved New Drugs
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Regulatory Intelligence & Drug Approvals4 weeks agoAmazon.com, Inc. – 736006 – 10/01/2026
Unapproved New Drugs
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Regulatory Intelligence & Drug Approvals4 weeks agoRoyceDerm LLC – 734781 – 10/01/2026
Unapproved New Drugs
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Regulatory Intelligence & Drug Approvals4 weeks agoBioactive Services USA, LLC / Herstat Inc. – 734784 – 10/01/2026
Unapproved New Drugs
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Regulatory Intelligence & Drug Approvals4 weeks agoTerramed – 735070 – 10/01/2026
Unapproved New Drugs
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Regulatory Intelligence & Drug Approvals4 weeks agoDesBio/Deseret Biologicals, Inc. – 735464 – 10/01/2026
Unapproved New Drugs
Helixgate Featured1 day ago
Widespread atropine use fails to sway FDA advisors on Sydnexis data
Helixgate Featured1 day ago
At least 11 PDUFAs on FDA’s November docket
Helixgate Featured1 day ago
FDA Grants Accelerated Approval to Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd) for Recurrent Respiratory Papillomatosis
Uncategorized7 months ago
Novartis buys Synnovation’s PI3Kα inhibitors for $3 billion
Endpoints News8 months ago
Novartis to pay $2B upfront to take next-gen PI3Kα inhibitor from Synnovation
Uncategorized6 months ago
