Cipla receives final approval for generic version of Migranal(Dihydroergotamine Mesylate Nasal Spray) with a Competitive Generic Therapy Designation Ruchika Sharma22 May 2020 1:44 PM ISTIt is indicated for the acute treatment of migraine headaches with or without aura
Dr Reddy's Labs gets USFDA EIR for Hyderabad facility Ruchika Sharma21 May 2020 2:44 PM ISTHyderabad: Dr Reddy's Labs has received Establishment Inspection Report (EIR) from USFDA for its formulations manufacturing plant-3 at Bachupally,...
Natco Pharma receives USFDA EIR for Vizag facility Ruchika Sharma21 May 2020 12:00 PM ISTAndhra Pradesh: Natco Pharma Limited has announced the successful closure of inspection and receipt of an Establishment Inspection Report (EIR) from...
Alembic Pharma JV gets USFDA nod for Clobetasol Propionate Shampoo Ruchika Sharma20 May 2020 1:19 PM ISTClobetasol Propionate Shampoo, 0.05% is indicated for the treatment of moderate to severe forms of scalp psoriasis in subjects 18 years of age and...
Laurus Labs gets USFDA nod for HIV drug Ruchika Sharma20 May 2020 12:12 PM ISTHyderabad: Laurus Labs Ltd has received approval from USFDA under President's Emergency Plan for AIDS Relief (PEPFAR) for two Abbreviated New Drug...
AstraZeneca, Daiichi Sankyo get USFDA Breakthrough Therapy status for lung cancer drug Enhertu Ruchika Sharma19 May 2020 12:32 PM ISTUK: AstraZeneca and Daiichi Sankyo Company, Limited has been granted Breakthrough Therapy Designation (BTD) in the US for the treatment of patients...
Bristol Myers gets USFDA nod to Opdivo, Yervoy combo for treating Lung Cancer Patients Farhat Nasim18 May 2020 5:18 PM ISTNew Delhi: Bristol Myers Squibb(BMS) recently announced that Opdivo (nivolumab) 3 mg/kg plus Yervoy (ipilimumab) 1 mg/kg (injections for...
Cipla files ANDA for generic version of Advair Diskus Ruchika Sharma18 May 2020 1:00 PM ISTIt is indicated as a twice-daily prescription medicine to treat asthma in patients aged four years and older
Zydus Cadila gets USFDA tentative nod for Droxidopa Capsules Ruchika Sharma18 May 2020 11:24 AM ISTAhemdabad: Drugmaker Zydus Cadila recently announced that the company has received tentative approval from the United States Food and Drug...
Sanofi gets USFDA priority review for sutimlimab for Hemolysis Ruchika Sharma17 May 2020 11:00 AM ISTParis: The U.S. Food and Drug Administration (FDA) has granted priority review of Sanofi's Biologics License Application (BLA) for sutimlimab for the...
Abbott rapid Covid-19 test potentially inaccurate, USFDA flags issue Ruchika Sharma16 May 2020 12:33 PM ISTThe researchers found that Abbott's test, run on the company's portable ID NOW system, missed one-third of the infections caught by Cepheid's test
Unichem Labs gets USFDA EIR for Roha API facility Ruchika Sharma16 May 2020 10:00 AM ISTMumbai: Unichem Laboratories Limited has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration...
