US FDA approves Bristol Myers Squibb’s CAR-T cell therapy Breyanzi for relapsed large B-cell…
In the pivotal phase-III Transform trial, single infusion of Breyanzi significantly outperformed the nearly 30-year standard of…
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Browsing Tag
US FDA approval
Zydus Lifesciences receives final approval from US FDA for Adapalene and Benzoyl Peroxide Topical…
A combination of Adapalene (a retinoid) and Benzoyl Peroxide (an antibiotic and skin-peeling agent), the gel is used to decrease…
GSK announces US FDA approval of Priorix for preventing Measles, Mumps and Rubella
Priorix is currently licensed in over 100 countries worldwide, including all European countries, Canada, Australia and New…
Zydus Lifesciences receives final approval from US FDA for Famotidine tablets
Famotidine is a histamine H2 receptor blocker
US FDA approves Roche’s Evrysdi for use in babies under two months with Spinal Muscular Atrophy
Approval based on interim Rainbowfish data which show pre-symptomatic babies treated with Evrysdi for at least one year were able…
Strides Pharma gets US FDA approval for generic Ibuprofen oral suspension
The product will be manufactured at the company’s facility in Bengaluru and will be marketed by Strides Pharma Inc in the US…
US FDA approves Novartis Kymriah CAR-T cell therapy for adult patients with relapsed or refractory…
68 per cent of patients receiving Kymriah in the Elara trial experienced complete response, with an 86 per cent overall response…
Alembic Pharma receives US FDA final approval for Pirfenidone tablets
Pirfenidone Tablets are indicated for the treatment of Idiopathic Pulmonary Fibrosis (IPF)
Sanofi’s Dupixent wins US approval for bigger use
Sanofi's regulatory filing for EoE is under review by the European Medicines Agency (EMA)
Glenmark Pharma receives ANDA approval for Abiraterone Acetate tablets USP, 500 mg
The tablets are a generic version of Zytiga Tablets, 500 mg, of Janssen Biotech