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FDA Approves Expanded Peripheral Artery Disease (PAD) Indication for XARELTO ® (rivaroxaban) Plus Aspirin to Include Patients After Lower-Extremity Revascularization (LER) Due to Symptomatic PAD
RARITAN, N.J., August 24, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded peripheral artery disease (PAD) indication for the XARELTO® (rivaroxaban) vascular dose (2.5 mg twice daily plus aspirin 100 mg once daily) to include patients following recent lower-extremity revascularization (LER) due to symptomatic PAD. The approval is based on data from the Phase 3 VOYAGER PAD study. With this approval, XARELTO® is the first and only therapy indicated to help reduce the risks of major cardiovascular (CV) events in p...
Source: Johnson and Johnson - August 24, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen Submits Application to U.S. FDA for New Indication to Expand Use of XARELTO ® (rivaroxaban) in Patients with Peripheral Artery Disease
RARITAN, NJ, October 26, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for a new indication to expand the use of XARELTO® (rivaroxaban) in patients with peripheral artery disease (PAD). If approved, this new indication for the XARELTO® vascular dose (2.5 mg twice daily plus aspirin 75-100 mg once daily) would include reducing the risk of major thrombotic vascular events such as heart attack, stroke and amputation in patients after recent lower-extremity revascularization, a c...
Source: Johnson and Johnson - October 26, 2020 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

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

Drug Safety: Fasinumab Evaluated in Clinical Trials, Plus Celecoxib May Not Pose Increased Heart Attack or Stroke Risk
After an independent review, ongoing clinical trials investigating the safety of fasinumab for treating hip or knee OA will discontinue the use of higher fasinumab doses...
Source: The Rheumatologist - May 15, 2018 Category: Rheumatology Authors: Michele B. Kaufman, PharmD, BCGP Tags: Drug Updates Safety celecoxib Drug Safety fasinumab FDA hip knee Knee Osteoarthritis (OA) Nonsteroidal anti-inflammatory drugs (NSAIDs) Pain Pain Management U.S. Food and Drug Administration (FDA) Source Type: research

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

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

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