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Tag: niraparib

You Searched For "niraparib"
Jemperli plus Zejula combo significantly improved progression-free survival in primary advanced or recurrent endometrial cancer: GSK

Jemperli plus Zejula combo significantly improved progression-free survival in primary advanced or recurrent endometrial cancer: GSK

Ruchika Sharma20 Dec 2023 2:30 PM IST
London: GSK plc has announced positive headline results from a planned analysis of Part 2 of the RUBY/ENGOT-EN6/GOG3031/NSGO phase III trial...
USFDA nod to JnJ Tremfya for Crohns disease

Janssen bags USFDA nod for Akeega to treat prostate cancer

Ruchika Sharma12 Aug 2023 11:35 AM IST
Horsham: The Janssen Pharmaceutical Companies of Johnson & Johnson has announced that the U.S. Food & Drug Administration (FDA) has...
FDA approves niraparib regimen for BRCA-mutated metastatic castration-resistant prostate cancer

FDA approves niraparib regimen for BRCA-mutated metastatic castration-resistant prostate cancer

Dr. Kamal Kant Kohli12 Aug 2023 10:15 AM IST
The Food and Drug Administration has approved the fixed dose combination of niraparib and abiraterone acetate (Akeega, Janssen Biotech, Inc.), with...
Janssen gets European Commission nod for AKEEGA to treat metastatic castration resistant prostate cancer with BRCA1/2 mutations

Janssen gets European Commission nod for AKEEGA to treat metastatic castration resistant prostate cancer with BRCA1/2 mutations

Ruchika Sharma22 April 2023 11:32 AM IST
The EC authorisation, which also marks the first worldwide approval for AKEEGA, is based on results of the randomised, double-blind, placebo...
Janssen seeks USFDA nod for Niraparib and Abiraterone Acetate Dual-Action Tablet, plus Prednisone to treat patients with Metastatic Castration-Resistant Prostate Cancer  with BRCA Gene Mutations

Janssen seeks USFDA nod for Niraparib and Abiraterone Acetate Dual-Action Tablet, plus Prednisone to treat patients with Metastatic Castration-Resistant Prostate Cancer with BRCA Gene Mutations

Ruchika Sharma2 March 2023 3:15 PM IST
Metastatic castration-resistant prostate cancer characterizes cancer that no longer responds to androgen deprivation therapy and has spread to other...
GSK Nucala application for COPD accepted for review in China

GSK gets CDSCO Panel nod to market anticancer Niraparib Tablet

Susmita Roy12 Oct 2022 6:00 PM IST
New Delhi: Granting the proposal of a local clinical trial waiver, the Subject Expert Committee (SEC) functional under the Central Drug Standard...
GSK Nucala application for COPD accepted for review in China

GSK announces USFDA committee to review Zejula overall survival data from NOVA phase III trial in recurrent ovarian cancer

Ruchika Sharma24 Sept 2022 5:41 PM IST
UK: GSK plc has announced that the US Food and Drug Administration (USFDA) will convene a meeting of the Oncologic Drugs Advisory Committee (ODAC) to...
GSK gets USFDA approval for Ovarian Cancer Drug Zejula

GSK gets USFDA approval for Ovarian Cancer Drug Zejula

Ruchika Sharma2 May 2020 9:30 AM IST
London: GlaxoSmithKline plc has announced the US Food and Drug Administration (FDA) approved the company's supplemental New Drug Application (sNDA)...

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