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 […]Read More
Shots: The first approval is for certain ESCC patients, which is based on P-III KEYNOTE-181 trial assessing Keytruda vs CT in patients with recurrent or metastatic ESCC whose tumors expressed PD-L1 (CPS ≥10). The study demonstrated mOS (10.3 vs 6.7mos.) Additionally, Keytruda received approval for use at an additional recommended dosage of 400mg, q6w, IV […]Read More
The US FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 48 new products so far in 2019. However, there is a significant increase in multiple diseases while the new approvals are helping and advancing the changes to understand, diagnose, and treat the diseases Our team […]Read More
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 […]Read More
Shots: The EC’s approval is based on PLUTO study assessing Benlysta (10 mg/kg IV) + SoC vs PBO + SoC in 93 children aged 5 – 11yrs. and 12 – 17yrs. with systemic lupus erythematosus for 1yr. The EC’s approval follows recent approval in the US & Japan The PLUTO study result: improvement in disease […]Read More
1.Janssen’s Erleada (apalutamide) Receives FDA Approval for Non-Metastatic Castration-Resistant Prostate Cancer (NM-CRPC) Published: 14 Feb,2018 | Tags: Janssen, Erleada, apalutamide, Receives, FDA, Approval, Non-Metastatic Castration-Resistant Prostate Cancer, NM-CRPC 2. Helsinn’s (fosnetupitant + palonosetron) Receives FDA Approval for Managing Chemotherapy-Induced Nausea and Vomiting (CINV) Published: 14 Feb,2018 | Tags: Helsins, fosnetupitant + palonosetron, Receives, FDA, Approval, […]Read More
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