Lupin gets USFDA EIR for Pithampur Unit-1 facility Ruchika Sharma1 May 2020 11:00 AM ISTMumbai: Lupin Limited has announced the receipt of the Establishment Inspection Report (EIR) from the United States Food and Drug Administration...
Lupin gets USFDA Tentative nod for Arformoterol Tartrate Inhalation Solution Ruchika Sharma30 April 2020 12:08 PM ISTMumbai, Baltimore: Lupin Limited has received tentative approval for its Arformoterol Tartrate Inhalation Solution 15 mcg (base)/2 mL, Unit-dose...
Glenmark Pharmaceuticals gets USFDA Tentative nod for Dapagliflozin, Saxagliptin Tablets Ruchika Sharma29 April 2020 4:14 PM ISTMumbai: Glenmark Pharmaceuticals Inc., USA has been granted tentative approval by the United States Food & Drug Administration for Dapagliflozin...
Natco Pharma gets USFDA nod for Vizag Formulation Facility Ruchika Sharma29 April 2020 12:58 PM ISTHyderabad: Natco Pharma Limited has announced the final approval of its 1st supplemental abbreviated new drug application (sANDA) product from the...
JB Chemicals gets US FDA nod for generic Tegretol XR tablet Ruchika Sharma28 April 2020 11:54 AM ISTMumbai: JB Chemicals & Pharmaceuticals Limited has announced that the US FDA has approved Company's Abbreviated New Drug Application (ANDA) for...
Granules India gets USFDA nod for Vigabatrin for Oral Solution Ruchika Sharma27 April 2020 1:01 PM ISTHyderabad: Granules India Limited has announced that the US Food & Drug Administration (US FDA) has approved the Abbreviated New Drug Application...
Natco Pharma gets USFDA EIR for Telangana facility Ruchika Sharma27 April 2020 10:49 AM ISTHyderabad: Natco Pharma Limited has announced the successful closure of inspection with an Establishment Inspection Report (EIR) from the U.S. Food...
Novartis Kymriah gets USFDA RMAT designation in follicular lymphoma Medical Dialogues Bureau26 April 2020 11:00 AM ISTKymriah, which is designed to be a one-time treatment, is the first-ever FDA-approved CAR-T cell therapy.
COVID-19 Battle: USFDA warns of major side effects of hydroxychloroquine, recommends use under close doctors supervision only Meghna A Singhania25 April 2020 12:30 PM ISTAdverse events included abnormal heart rhythms such as QT interval prolongation, dangerously rapid heart rate called ventricular tachycardia and...
Granules India gets USFDA nod for Trospium Chloride ER Capsules Ruchika Sharma25 April 2020 11:32 AM ISTHyderabad: Granules India Limited has announced that the US Food & Drug Administration (US FDA) has approved the Abbreviated New Drug Application...
USFDA approves plasma therapy trial at Columbia, Amazon gives $2.5 million grant MD Bureau24 April 2020 1:51 PM ISTNew York: The US health regulator Food and Drug Administration (FDA) has granted approval to the Columbia University to launch clinical...
US FDA, EMA accepted applications for OCREVUS (ocrelizumab) shorter 2-hour infusion time: Roche Ruchika Sharma22 April 2020 1:25 PM ISTBasel: Roche has announced that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental Biologics License Application...
