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Regulatory Updates

FDA Accepts sBLA for Atezolizumab + Abraxane and Carboplatin for Metastatic...

The United States Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for atezolizumab (Tecentriq®; Roche/Genentech) in combination with albumin-bound...

INmune Bio Receives Phase I Clinical Trial Authorization for Lead Product...

INmune Bio, a clinical-stage biotechnology company developing anti-cancer therapies to reprogram the innate immune system to fight disease, has received Clinical Trial Authorization (CTA)...

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...

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