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Johnson & Johnson submits new drug application to FDA seeking expand pediatric indication for HIV-1 therapy Prezcobix

Written by | 8 Jun 2024

Johnson & Johnson announced the submission of a supplemental New Drug Application (sNDA) to the FDA seeking to expand the indication of Prezcobix (darunavir/cobicistat) to include the treatment… read more.

FDA approves Edurant Ped (rilpivirine) for certain pediatric patients Living with HIV-1 – Johnson & Johnson

Written by | 4 Apr 2024

Johnson & Johnson announced that the FDA has approved Edurant Ped (rilpivirine) for the treatment of HIV-1 in combination with other antiretroviral therapies (ARVs) in treatment-naïve children (with… read more.

Spravato (esketamine) demonstrates superior efficacy compared to quetiapine extended-release in treatment-resistant major depressive disorder – Johnson & Johnson

Written by | 21 Oct 2023

An open-label, international study published in the New England Journal of Medicine found that patients receiving Spravato (esketamine) CIII nasal spray for treatment-resistant depression (TRD) were 1.54 times… read more.

New comprehensive phase III data show first-in-class Tremfya provided durable improvements in measures of psoriatic arthritis through two years – Johnson & Johnson

Written by | 24 Jan 2022

The Janssen Pharmaceutical Companies of Johnson & Johnson announced comprehensive efficacy and safety data from the DISCOVER–2 trial of Tremfya (guselkumab) were published in Arthritis & Rheumatology, representing… read more.

Booster of COVID-19 vaccine administered six months after two-dose regimen of BNT162b2, shows substantial increase in antibody and T-cell responses – Johnson & Johnson

Written by | 3 Jan 2022

Johnson & Johnson announced preliminary results from an independent study, including a subset of participants from the Janssen-sponsored COV2008 study, conducted by Dan Barouch, M.D., Ph.D., et al…. read more.

Ebola Vaccine Regimen demonstrated robust and durable immune response in adults and children in data published in The Lancet Infectious Diseases – Johnson & Johnson

Written by | 7 Oct 2021

Data from two papers published in The Lancet Infectious Diseases demonstrated that the Johnson & Johnson (the Company) Ebola vaccine regimen, Zabdeno (Ad26.ZEBOV) and Mvabea (MVA-BN-Filo), generated robust… read more.

Johnson & Johnson announces real-world evidence and phase III data confirming strong and long-lasting protection of single-shot COVID-19 vaccine in the U.S.

Written by | 3 Oct 2021

Johnson & Johnson announced new data reinforcing the strong and long-lasting protection of its COVID-19 vaccine . New data also showed that protection against COVID-19 increases when a… read more.

Johnson & Johnson single-shot COVID-19 vaccine demonstrated a durable immune response and elicited dual mechanisms of protection against delta and other SARS-CoV-2 variants in data published in NEJM

Written by | 30 Jul 2021

Interim results from a Phase 1/IIa sub-study published in the New England Journal of Medicine (NEJM) demonstrated that both humoral (antibody) and cellular (T-cell) immune responses generated by… read more.

Positive new data for Johnson & Johnson single-shot COVID-19 vaccine on activity against Delta variant and long-lasting durability of response

Written by | 18 Jul 2021

Johnson & Johnson announced data that demonstrated its single-shot COVID-19 vaccine generated strong, persistent activity against the rapidly spreading Delta variant and other highly prevalent SARS-CoV-2 viral variants…. read more.

TGA Australia approves COVID-19 vaccine Janssen to prevent COVID-19 – Janssen Cilag Pty. Ltd.

Written by | 29 Jun 2021

On 25 June 2021 the Therapeutic Goods Administration (TGA) granted provisional approval to Janssen-Cilag Pty Ltd (known as Johnson & Johnson overseas) for its COVID-19 vaccine Janssen, making… read more.

Johnson & Johnson single-shot COVID-19 vaccine phase III data published in New England Journal of Medicine

Written by | 28 Apr 2021

Johnson & Johnson announced publication in the New England Journal of Medicine of primary data from the Phase III ENSEMBLE clinical trial for its single-dose COVID-19 vaccine, developed… read more.

FDA announce that vaccinations with JNJ 78436735 for COVID-19 can restart – Johnson & Johnson

Written by | 26 Apr 2021

Johnson & Johnson announced that vaccinations with JNJ 78436735, the Company’s COVID-19 single-shot vaccine, will resume for all adults aged 18 years and older in the U.S., under… read more.

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