Johnson & Johnson Submits NDA to the US FDA for TAR-200 to Treat BCG-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC)

Shots: FDA received NDA of TAR-200 (J&J) for the treatment of Bacillus Calmette-Guérin (BCG) -unresponsive HR-NMIBC with CIS &/or papillary tumors the application will be reviewed under RTOR pathway, following receipt of BTD in Dec 2023 The NDA was supported by the P-IIb (SunRISe-1) trial, assessing TAR-200 in patients ineligible or opting out of…

ByRidhi RastogiJanuary 17, 2025

INSIGHTS+

Insights+: The US FDA New Drug Approvals in January 2024

Shots: The US FDA approved 1 NDA in January 2024, leading to treatments for patients and advances in the healthcare industry In January 2023, Zelsuvmi was approved by the US FDA for the Treatment of Molluscum Contagiosum PharmaShots has compiled a list of US FDA-approved drugs in the month January 2024 1. Ligand Pharmaceuticals’ Zelsuvmi Receives…

BySenior EditorFebruary 8, 2024

THOUGHTSPOT

What are the Services Offered by Gastroenterologist?

Introduction A gastroenterologist is a professional who diagnoses stomach and digestive problems. An individual can only focus on his daily chores if his health is fit and fine. Nowadays, individuals suffer from various digestive issues, and if these symptoms are ignored, they can lead to a severe problem. A professional gastroenterologist possesses a variety of…

ByHaikle LeeSeptember 25, 2023

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Insights+: The US FDA New Drug Approvals in January 2021

The US FDA has approved 4 NDAs in Jan 2021, leading to treatments for patients and advances in the health care industry. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 4 novel products in 2021. Additionally, last year in 2020, the US FDA has approved…

BySenior EditorFebruary 18, 2021

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Insights+: The US FDA New Drug Approvals in February 2020

The US FDA has approved multiple NDAs and BLAs in Feb 2020, leading to treatments for patients and advances in health care The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 13 novel products so far in 2020, including 10 in Feb and 3 in Jan…

BySenior EditorMarch 27, 2020

Johnson & Johnson Submits NDA to the US FDA for TAR-200 to Treat BCG-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC)

Insights+: The US FDA New Drug Approvals in January 2024

What are the Services Offered by Gastroenterologist?

Insights+: The US FDA New Drug Approvals in January 2021

Insights+: The US FDA New Drug Approvals in February 2020

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