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Home › Posts tagged Tisagenlecleucel (Kymriah)

Tag: Tisagenlecleucel (Kymriah)

The first gene therapy FDA approved in the US

By Joseph Gut - thasso Posted on September 3, 2017 Posted in Gene Therapy, New Drug Approval, Personalized Medicine, Regulatory Approval, Thasso Post, Theragenomic Medicine No Comments Tagged with American Food & Drug Administration (FDA), B-Cell Acute Lymphoblastic Leukemia (B-Cell ALL), Boxed Warning, CAR T-Cell Therapy, CD19, Cytokine Release Syndrome (CRS), Gene Therapy, Immunetherapy, Risk Evaluation Mitigation Strategy (REMS), Thasso Post, Tisagenlecleucel (Kymriah), Tocilizumab (Actemra)
The first gene therapy FDA approved in the US

September 3, 2017 – For a very first time, the American Food & Drug Administration (FDA) has approved a gene therapy for the United States (US) in that it approved CAR T-cell therapy to treat certain children and young adults with …

The first gene therapy FDA approved in the US Read more »

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RSS FDA press releases

  • FDA Developing New Framework for Continued, Expanded Access to Infant Formula Options for U.S. Parents and Caregivers July 6, 2022
  • Coronavirus (COVID-19) Update: FDA Authorizes Pharmacists to Prescribe Paxlovid with Certain Limitations July 6, 2022
  • FDA Infant Formula Update: July 6, 2022 July 6, 2022
  • FDA Roundup: July 5, 2022 July 5, 2022
  • FDA Roundup: July 1, 2022 July 1, 2022

RSS FDA MedWatch

  • Getinge USA Sales Inc Recalls Flow-c and Flow-e Anesthesia Systems for Cracked or Broken Suction System Power Switches July 6, 2022
  • 2022 Medical Device Recalls July 6, 2022
  • Mylan Pharmaceuticals Inc., a Viatris Company, Issues Voluntary Nationwide Recall of One Batch of Insulin Glargine (Insulin glargine-yfgn) Injection Pens, 100 units/mL (U-100), Due to the Potential of Missing Labels on Some Pens July 6, 2022
  • Information Regarding Medically Necessary Specialty Infant Formulas: Notice to Health Care Providers July 1, 2022
  • Use Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication June 30, 2022

RSS EMA Press releases

  • Global regulators agree on key principles on adapting vaccines to tackle virus variants, , 01/07/2022 July 1, 2022
  • Assessing dietary exposure to residues of veterinary medicines, feed additives and pesticides in food of animal origin in the EU, CVMP, 30/06/2022 June 30, 2022
  • Call for companies to register their Industry Single Point of Contact (i-SPOC) on supply and availability, , 28/06/2022 June 28, 2022
  • Monkeypox: EMA starts review for Imvanex, CHMP, 28/06/2022 June 28, 2022
  • Hydroxyethyl-starch solutions for infusion recommended for suspension from the market, CMDh, 25/02/2022 June 27, 2022

RSS random genetics

  • New sickle cell disease gene therapies depend on getting the right mouse July 6, 2022
    Sickle cell disease is an extremely debilitating condition that affects up to 40% of the population in African countries, with patients suffering episodes of excruciating pain, organ damage and reduced life expectancy. This disease is caused by a mutation in a gene that makes hemoglobin, the protein that carries oxygen in red blood cells, with […]
  • Pneumonia risk signals and their potential for precision medicine July 6, 2022
    The largest ever genomic study of pneumonia has identified the genetic risk signals of the disease, paving the way for potential new treatments and the use of precision medicine.
  • Testing embryos for genetic conditions: Who is eligible and how are decisions made? July 6, 2022
    With advances in medical technology, embryos can be genetically screened before being implanted in the womb during IVF. Couples at risk for certain genetic conditions can now safely conceive children who will not inherit these conditions. However, establishing when such treatment is justified raises complex questions.
  • New research maps possible molecular origins of kidney disease July 6, 2022
    After mapping the genetic underpinning of kidney function in 1.5 million people and about 60,000 kidney cells that are the microscopic mechanisms of gene regulation, researchers at the Perelman School of Medicine at the University of Pennsylvania found that more than 500 genes likely contribute to kidney disease development. Multiple genes that play a key […]
  • Study reveals why highly infectious cholera variant mysteriously died out July 5, 2022
    A new study reveals why a highly infectious variant of the cholera bug, which caused large disease outbreaks in the early 1990s, did not cause the eighth cholera pandemic as feared—but instead unexpectedly disappeared.

Recent Comments

  • David Walliams on Is genetic testing of value for ALS patients?: “CURED FROM GENITAL HERPES More than 5 years ago I was in pain with this deadly herpes virus, A few…” Nov 7, 16:08
  • Raul Malkovic on Is genetic testing of value for ALS patients?: “HOW MY WIFE GOT CURED FROM ALS Below is how i got a cure for my wife who suffered from Amyotrophic Lateral Sclerosis…” Nov 6, 21:18
  • Pamela Erickson on Is genetic testing of value for ALS patients?: “My husband was diagnosed with ALS (amyotrophic lateral sclerosis) when he was 63 years old 4 years ago. The Rilutek…” Aug 13, 13:04
  • thassodotcom on Unlucky women with BIA-ALCL: An update: “The Therapeutic Goods Agency (TGA) of Australia has just issued a hazard alert concerning the risk of breast implant-associated anaplastic…” Aug 4, 09:17
  • thassodotcom on Tofacitinib (Xeljanz): Dangers of blood clots in the lungs and of death: “According to its Drug Safety Communication from 07/26/2019, the FDA has approved new warnings about an increased risk of blood…” Aug 4, 08:40

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Adverse Drug Reaction (ADR) African American Allelic Variant American Food & Drug Administration (FDA) American Food & Drug Administration (FDA) Boxed Warning Breast Cancer Canagliflozin (Invokana) Children Clinical Trial Committee for Medicinal Products for Human Use (CHMP) Companion Test Covid-19 Disease Diabetes Drug Induced Liver Injury (DILI) Empagliflozin [Jardiance] Epidermal Growth Factor Receptor (EGFR) Erectile Dysfunction Ethnicity European Medicine Agency (EMA) European Medicines Agency (EMA) Food and Drug Administration (FDA) Gene Therapy Genetic Background Genetic Predisposition Genetic Testing Health Canada Non-Small Cell Lung Cancer (NSCLC) Obesity Pembrolizumab [Keytruda] Personalized Medicine Phenotype Progressive Multifocal Leukoencephalopathy (PML) Rare Disease Risk Evaluation and Mitigation Strategy (REMS) SARS-CoV-2 Schizophrenia Sodium-Glucose Cotransporter-2 (SGLT2) Stevens Johnson Syndrome [SJS] Targeted Therapy ThassoBase Thasso Post Theragenomic Medicine Type 2 Diabetes Vemurafenib [Zelboraf]

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