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Regulatory Updates

FDA Approves Larotrectinib – the First Tumor-agnostic Cancer Treatment

The U.S. Food and Drug Administration (FDA) has granted accelerated approval for larotrectinib (Vitrakvi® ; Bayer), also know as LOXO-101/ARRY-470 to Loxo Oncology. The...

Glasdegib Approved in Newly-Diagnosed AML Patients for Whom Intensive Chemotherapy is...

The U.S. Food and Drug Administration (FDA) has approved glasdegib, also known as PF-04449913 (Daurismo™; Pfizer), a once-daily oral smoothened (SMO) inhibitor for the treatment...

FDA Grants Accelerated Approval for Venetoclax in Newly-Diagnosed Acute Myeloid Leukemia...

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to venetoclax (Venclexta®; Genentech/Roche and Abbvie), in combination with a hypomethylating agent (azacitidine...

European Commission Approves Pegfilgrastim Biosimilar Pelmeg

The European Commission has granted approval for the use of Pelmeg®, also known as B12019, (pegfilgrastim biosimilar) as a treatment for reduction in the duration...

FDA Approval of Emapalumab Marks Significant Improvement in Primary HLH Induction...

The U.S. Food and Drug Administration (FDA) has approved emapalumab-lzsg (Gamifant®  previously known as NI-0501) a novel fully human interferon gamma (IFNγ)–blocking antibody developed...

Increased Popularity of E-cigarettes Results in Alarming Rise of Young Smokers

Findings from the National Youth Tobacco Survey (NYTS) released by the U.S. Food and Drug Administration and U.S. Centers for Disease Control and Prevention...

European Medicines Agency Validates and Grants Accelerated Assessment for Quizartinib in...

The European Medicines Agency (EMA) validated for review and granted accelerated assessment to the Marketing Authorization Application for quizartinib, an investigational oral selective FLT3...

New Data Supports Use of Real-World Evidence to Assess Long-term Impact...

Friends of Cancer Research, an organization focusing on the collaboration among partners from every healthcare sector to power advances in science, policy and regulation...

Why Do We Need a Right-to-Try Bill in America?

Congress recently passed, and President Trump signed, the “Right to Try” bill that gives dying patients limited access to drugs that have not yet...

U.S. FDA Grants Accelerated Approval for Neoadjuvant use of Pertuzumab in...

Earlier today, the U.S. Food and Drug Administration (FDA) granted accelerated approval of a pertuzumab (Perjeta®, Genentech/Roche) regimen for neoadjuvant treatment in patients with...

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