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Tag: gsk

You Searched For "gsk"
GSK Blujepa bags USFDA nod for treatment of uUTIs in female adults, paediatric patients 12 years of age and older

CDSCO Panel Approves GSK Protocol Amendment proposal for Belrestotug and Dostarlimab study

Dr. Divya Colin27 Dec 2024 5:30 PM IST
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has approved the drug major...
Jemperli bags USFDA Breakthrough Therapy Designation for locally advanced dMMR/MSI-H rectal cancer: GSK

Jemperli bags USFDA Breakthrough Therapy Designation for locally advanced dMMR/MSI-H rectal cancer: GSK

Ruchika Sharma16 Dec 2024 1:30 PM IST
London: GSK plc has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for Jemperli...
GSK Blenrep combos receive positive EMA Committee opinion in relapsed/refractory multiple myeloma

Blenrep combo accepted for priority review in China in relapsed/refractory multiple myeloma: GSK

Ruchika Sharma11 Dec 2024 1:30 PM IST
London: GSK plc has announced that the National Medical Products Administration (NMPA) of China has accepted for review a new drug application...
GSK Shingrix new prefilled syringe

USFDA accepts GSK submission for use of Nucala in COPD

Ruchika Sharma11 Dec 2024 11:30 AM IST
London: GSK plc has announced the US Food and Drug Administration (FDA) has accepted for review, data from the MATINEE study to support the...
WHO unveils new guideline to improve global access to controlled medicines

Tafenoquine: WHO awards prequalification to single-dose medicine for P. vivax malaria

Ruchika Sharma5 Dec 2024 12:30 PM IST
London: GSK plc and Medicines for Malaria Venture (MMV) has announced that the World Health Organization (WHO) has awarded prequalification to...
GSK RSV vaccine Arexvy

GSK fully liquid Menveo meningococcal vaccine approved by European Commission

Ruchika Sharma29 Nov 2024 12:39 PM IST
London: GSK plc has announced that the European Commission (EC) has approved a single-vial, fully liquid presentation of...
GSK RSV vaccine Arexvy

USFDA accepts for review application for GSK Blenrep combinations for multiple myeloma treatment

Ruchika Sharma26 Nov 2024 5:52 PM IST
London: GSK plc has announced the US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for...
ASCI Flags 233 Health Ads for DMR Act Violation, Reports to AYUSH Ministry

GSK's Augmentin Leads Indian Pharma Market in October with Rs 843 Crore Sales: Pharmatrac Report

Farhat Nasim22 Nov 2024 5:40 PM IST
New Delhi: As the Indian Pharmaceutical Market (IPM) continues its upward trajectory, Augmentin by GlaxoSmithKline (GSK) has stood the test of time...
GSK Blujepa bags USFDA nod for treatment of uUTIs in female adults, paediatric patients 12 years of age and older

GSK, Vesalius Therapeutics collaborate for novel treatments for Parkinson's disease

Ruchika Sharma16 Nov 2024 12:35 PM IST
Cambridge: Vesalius Therapeutics, a company pioneering a revolutionary platform to deliver breakthrough treatments for common diseases, has...
GSK RSV vaccine Arexvy

GSK Ojjaara approved in Canada for treatment of myelofibrosis in adults who have moderate to severe anemia

Ruchika Sharma14 Nov 2024 1:15 PM IST
Mississauga: GSK has announced that Health Canada has approved Ojjaara (momelotinib) for the treatment of splenomegaly and/or...
Expanded age indication for GSK’s AREXVY

GSK RSV vaccine approved in Canada for adults aged 50-59 at increased risk

Ruchika Sharma11 Nov 2024 1:00 PM IST
Mississauga: GSK's AREXVY (respiratory syncytial virus vaccine - recombinant, AS01E adjuvanted) has been approved in Canada for the prevention of...
SEC Asks Abbott to Submit More Data on Vitamin C Plus D3 FDC Chewable Tablet, Cites Lack of Justification

Abbott's review plea challenging NPPA ceiling price fixation of 18 formulations rejected by DoP

Farhat Nasim16 Oct 2024 4:59 PM IST
New Delhi: The Department of Pharmaceuticals (DoP) has dismissed two review applications filed by Abbott Healthcare Private Limited (AHPL) challenging...
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