FDA approves new therapy for triple negative breast cancer that has spread, not responded to other…
The FDA granted approval of Trodelvy to Immunomedics
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Browsing Tag
US FDA
Aurobindo Pharma gets VAI classification from US regulator for Hyderabad unit
The inspection of Unit IV at Hyderabad, an injectable manufacturing formulation facility of the company, was conducted between…
US FDA approves first therapy for treatment of low-grade Upper Tract Urothelial Cancer
This is the first approval specifically for patients with low-grade UTUC and provides an option for some patients who may…
Lupin’s Mandideep Unit II Facility Receives EIR from US FDA
The inspection at the facility was carried out by the US FDA between November 26, 2018 and December 4, 2018
Lupin’s Nagpur Facility Receives EIR from US FDA
The inspection for the facility was carried out by the US FDA between January 6, 2020 and January 10, 2020
Hydroxychloroquine consignment from India arrives in the US
The US has bought more than 29 million doses of hydroxychloroquine for COVID-19 patients
Aurobindo Pharma gets US FDA nod for generic antidepressant tablets
The tablets are generic version of Eli Lilly's Prozac tablets
Granules India gets USFDA approval for Butalbital, Acetaminophen, Caffeine capsules
Butalbital, Acetaminophen and Caffeine Capsules are used to treat tension headaches
Cipla receives final approval for generic version of Proventil HFA Inhalation Aerosol
Cipla’s Albuterol Sulfate Inhalation Aerosol 90mcg (base)/actuation, is the first AB-rated generic therapeutic equivalent version…
Lupin’s Aurangabad Facility Receives EIR from US FDA
The inspection for the facility was carried out between February 10, 2020 and February 14, 2020 and concluded with no observations