Zydus Cadila receives tentative approval from US FDA for Brexpiprazole tablets
The drug will be manufactured at the group’s formulation manufacturing facility at the SEZ, Ahmedabad
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US FDA approval
Zydus Cadila’s Sitagliptin base tablets receive tentative approval from FDA
Zydus’ NDA received tentative approval upon completion of the first review cycle on 2nd September, 2021
FDA approves Cara’s drug for severe itching in kidney disease patients
The drug is designed to be administered three times a week after each dialysis
FDA approves first COVID-19 vaccine
Since 11th December, 2020, the Pfizer-BioNTech COVID-19 vaccine has been available under EUA in individuals 16 years of age and…
Zydus Cadila gets US FDA approval for Tofacitinib extended-release 22 mg tablet
Zydus was the first ANDA filer on Tofacitinib extended-release tablets 22 mg and
currently holds 180-day exclusivity on this…
US FDA approves Jardiance to treat adults living with heart failure with reduced ejection fraction
Heart failure accounts for more than one million hospitalisations a year in the US
GSK receives US FDA approval for Jemperli to treat advanced solid tumours
GARNET study demonstrated an objective response rate of 41.6 per cent across dMMR solid tumours
Lupin receives tentative US FDA approval for Brivaracetam tablets
The product will be manufactured at Lupin’s Nagpur facility in India
USFDA gives nod to Cipla’s generic product
According to IQVIA (IMS Health), Durezol had US sales of around $106 million for the 12-month period ending June 2021
US FDA grants priority review to Roche’s Tecentriq as adjuvant treatment for non-small cell lung…
Tecentriq is the first and only cancer immunotherapy to demonstrate positive phase-III results in the adjuvant lung cancer setting…