Filtered By:
Management: Food and Drug Administration (FDA)
Vaccination: Cancer Vaccines
This page shows you your search results in order of date.
Order by Relevance | Date
Total 15 results found since Jan 2013.
FDA Experts Vote to Make All COVID-19 Vaccines and Boosters Bivalent
In a unanimous decision, all 21 voting members of the U.S. Food and Drug Administration’s (FDA) vaccine committee recommended that the U.S. start using the same COVID-19 virus strain in all of the COVID-19 vaccines, including primary and booster doses.
That means the bivalent booster dose, which targets both the original SARS-CoV-2 strain and the Omicron BA.4/5 strains, would soon become the only type used for all primary shots and boosters.
The decision reflects a turning point in the pandemic. Until now, vaccine makers have tried to keep up with constantly evolving variants, but they’ve always been a few step...
Source: TIME: Health - January 27, 2023 Category: Consumer Health News Authors: Alice Park Tags: Uncategorized COVID-19 healthscienceclimate Source Type: news
How AI Is Changing Medical Imaging to Improve Patient Care
That doctors can peer into the human body without making a single incision once seemed like a miraculous concept. But medical imaging in radiology has come a long way, and the latest artificial intelligence (AI)-driven techniques are going much further: exploiting the massive computing abilities of AI and machine learning to mine body scans for differences that even the human eye can miss.
Imaging in medicine now involves sophisticated ways of analyzing every data point to distinguish disease from health and signal from noise. If the first few decades of radiology were about refining the resolution of the pictures taken of...
Source: TIME: Health - November 4, 2022 Category: Consumer Health News Authors: Alice Park and Video by Andrew D. Johnson Tags: Uncategorized Frontiers of Medicine 2022 healthscienceclimate Innovation sponsorshipblock Source Type: news
U.S. FDA Approves TECVAYLI ™ (teclistamab-cqyv), the First Bispecific T-cell Engager Antibody for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma
HORSHAM, Pa., October 25, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) approved TECVAYLI™ (teclistamab-cqyv) for the treatment of adult patients with relapsed or refractory multiple myeloma, who previously received four or more prior lines of therapy, including a proteasome inhibitor, immunomodulatory drug and anti-CD38 monoclonal antibody.1 TECVAYLI™ is a first-in-class, bispecific T-cell engager antibody that is administered as a subcutaneous treatment.1 This off-the-shelf (or ready to use) therapy uses innovative science to ac...
Source: Johnson and Johnson - October 25, 2022 Category: Pharmaceuticals Tags: Innovation Source Type: news
New ERLEADA ® (apalutamide) Analysis Demonstrates Rapid, Deep Prostate-Specific Antigen (PSA) Response in Patients with Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
SAN FRANCISCO, Feb. 14, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new real-world evidence data showing the initiation of ERLEADA® (apalutamide) results in high rates of rapid and deep prostate-specific antigen (PSA) response among patients with metastatic castration-sensitive prostate cancer (mCSPC). In a separate post-hoc analysis of the registrational Phase 3 SPARTAN and TITAN studies, rapid and deep PSA responses with ERLEADA® were associated with improvement in patient-reported outcomes (PROs) related to quality of life, physical wellbeing, pain, and fatigue intensity. The...
Source: Johnson and Johnson - February 14, 2022 Category: Pharmaceuticals Tags: Innovation Source Type: news
FDA Approves Two New Indications for XARELTO ® (rivaroxaban) to Help Prevent and Treat Blood Clots in Pediatric Patients
RARITAN, NJ, Dec. 20, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved two pediatric indications for XARELTO® (rivaroxaban): the treatment of venous thromboembolism (VTE, or blood clots) and reduction in the risk of recurrent VTE in patients from birth to less than 18 years after at least five days of initial parenteral (injected or intravenous) anticoagulant treatment; and thromboprophylaxis (prevention of blood clots and blood-clot related events) in children aged two years and older with congenital heart disease who have...
Source: Johnson and Johnson - December 21, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
Janssen to Present the Strength and Promise of its Hematologic Malignancies Portfolio and Pipeline at ASH 2021
RARITAN, N.J., November 4, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that more than 45 company-sponsored abstracts, including 11 oral presentations, plus more than 35 investigator-initiated studies will be featured at the American Society of Hematology (ASH) Annual Meeting and Exposition. ASH is taking place at the Georgia World Congress Center in Atlanta and virtually from December 11-14, 2021.“We are committed to advancing the science and treatment of hematologic malignancies and look forward to presenting the latest research from our robust portfolio and pipeline during ASH...
Source: Johnson and Johnson - November 5, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
ERLEADA ® (apalutamide) Oral Presentations Demonstrate Importance of Prostate Specific Antigen (PSA) as Key Efficacy Indicator and Show Strong Patient Adherence Rates
September 11, 2021 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new data demonstrating robust prostate-specific antigen (PSA) response and strong adherence rates in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) treated with ERLEADA® (apalutamide) in the real-world clinical setting. The strong PSA response was also seen in a separate post-hoc analysis that showed a correlation between rapid and deep PSA response and prolonged survival in both metastatic castration-sensitive prostate cancer (mCSPC) and nmCRPC. The post-hoc analysis also suppor...
Source: Johnson and Johnson - September 12, 2021 Category: Pharmaceuticals Source Type: news
Janssen Demonstrates Commitment to Advancing Science and Innovation in the Treatment of Solid Tumors at ESMO Annual Congress
September 8, 2021 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that more than ten data presentations from its lung cancer, bladder cancer and prostate cancer portfolio and pipeline will be featured during the European Society for Medical Oncology (ESMO) Annual Congress 2021 virtual meeting, September 16–21. Further details about these data and the science Janssen is advancing will be made available throughout ESMO via the Janssen Oncology Virtual Newsroom.“With a diverse oncology portfolio and pipeline spanning bladder cancer, lung cancer and prostate cancer, Janssen...
Source: Johnson and Johnson - September 8, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
Janssen Announces U.S. FDA Approval of PONVORY ™ (ponesimod), an Oral Treatment for Adults with Relapsing Multiple Sclerosis Proven Superior to Aubagio® (teriflunomide) in Reducing Annual Relapses and Brain Lesions
TITUSVILLE, N.J. – (March 19, 2021) – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) approved PONVORY™ (ponesimod), a once-daily oral selective sphingosine-1-phosphate receptor 1 (S1P1) modulator, to treat adults with relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease.1,2,3 PONVORY™ offers MS patients superior efficacy in reducing annualized relapse rates compared to an established oral therapy and a proven safety profile backed by ove...
Source: Johnson and Johnson - March 19, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
Johnson & Johnson Reports 2020 Third-Quarter Results
New Brunswick, N.J. (October 13, 2020) – Johnson & Johnson (NYSE: JNJ) today announced results for third-quarter 2020. “Our third-quarter results reflect solid performance and positive trends across Johnson & Johnson, powered by better-than-expected procedure recovery in Medical Devices, growth in Consumer Health, and continued strength in Pharmaceuticals,” said Alex Gorsky, Chairman and Chief Executive Officer. “I am proud of the relentless passion and Credo-led commitment to patients and customers that our colleagues around the world continue to demonstrate as we boldly fight the COVID-19 pandemic. Our wo...
Source: Johnson and Johnson - October 13, 2020 Category: Pharmaceuticals Tags: Our Company Source Type: news
Novartis ’ Spinal Drug Gets FDA Approval, $2 Million Price Tag
(CNN) — The US Food and Drug Administration approved a treatment Friday for a genetic disease called spinal muscular atrophy that causes infants’ muscles to waste away, potentially killing them before age 2.
And then came the price tag: $2.125 million for a one-time treatment.
The gene therapy, called Zolgensma, will be marketed by AveXis, whose parent company is Novartis.
“Today’s approval marks another milestone in the transformational power of gene and cell therapies to treat a wide range of diseases,” Dr. Ned Sharpless, the FDA’s acting commissioner, said in a statement Friday. ̶...
Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - May 24, 2019 Category: Consumer Health News Authors: Health – CBS Boston Tags: Health News CNN Novartis Source Type: news
UCLA helps many to live long and prosper
In Westwood, more than 100 faculty experts from 25 departments have embarked on anall-encompassing push to cut the health and economic impacts of depression in half by the year 2050. The mammoth undertaking will rely on platforms developed by the new Institute for Precision Health, which will harness the power of big data and genomics to move toward individually tailored treatments and health-promotion strategies.On the same 419 acres of land, researchers across the spectrum, from the laboratory bench to the patient bedside, are ushering in a potentially game-changing approach to turning the body ’s immune defenses again...
Source: UCLA Newsroom: Health Sciences - November 9, 2017 Category: Universities & Medical Training Source Type: news
Stem Cells for Cell-Based Therapies
The world of stem cells
We know the human body comprises many cell types (e.g., blood cells, skin cells, cervical cells), but we often forget to appreciate that all of these different cell types arose from a single cell—the fertilized egg. A host of sequential, awe-inspiring events occur between the fertilization of an egg and the formation of a new individual:
Embryonic stem (ES) cells are also called totipotent cells.
The first steps involve making more cells by simple cell division: one cell becomes two cells; two cells become four cells, etc.
Each cell of early development is undifferentiated; that is, it is...
Source: ActionBioscience - December 28, 2012 Category: Science Authors: Ali Hochberg Source Type: news
