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…
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Browsing Tag
US FDA approval
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…
Zydus Cadila receives final approval from US FDA for Fulvestrant injection
The drug will be manufactured at the group’s formulation manufacturing facility at Zydus Biologics, Ahmedabad
US FDA approves Shingrix to prevent shingles in immuno-compromised adults
Shingrix, a non-live, recombinant sub-unit adjuvanted vaccine, given intramuscularly in two doses, was initially approved by FDA…
Merck gets US FDA nod of adult pneumococcal 15-valent conjugate vaccine
VAXNEUVANCE demonstrated non-inferior immune responses for the serotypes shared with PCV13 (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C,…