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Fresenius Kabi Oncology Ltd to pay $50mn for destroying records ahead of an FDA Inspection europeanpharmaceuticalreview
February 19, 2021
The Indian drug company pleaded guilty to concealing and destroying records containing evidence of its Kalyani plant manufacturing drugs in contravention to FDA requirements prior to a 2013 inspection.
FDA clears Altimmune’s IND application for Covid-19 vaccine candidate trial pharmaceutical-technology
February 19, 2021
The US Food and Drug Administration (FDA) has cleared Altimmune’s Investigational New Drug (IND) application for its Phase I clinical trial of an intranasal Covid-19 vaccine candidate, AdCOVID.
FDA Grants Sotorasib Priority Review Designation for Advanced, Metastatic NSCLC americanpharmaceuticalreview
February 19, 2021
Amgen announced the U.S. Food and Drug Administration (FDA) has granted Priority Review for sotorasib for the treatment of patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) ...
Verrica Announces FDA Filing Acceptance for VP-102 for Molluscum Contagiosum americanpharmaceuticalreview
February 19, 2021
Verrica Pharmaceuticals announced its resubmitted New Drug Application (NDA) for VP-102 (cantharidin 0.7% Topical Solution), a proprietary topical therapy for the treatment of molluscum contagiosum (molluscum), has been accepted for filing by the ...
Entresto Granted Expanded Indication in Chronic Heart Failure by FDA americanpharmaceuticalreview
February 19, 2021
Novartis announced the US Food and Drug Administration (FDA) has approved the following expanded indication for Entresto® (sacubitril/valsartan) to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with ...
Targovax Receives Fast-Track Designation for ONCOS-102 americanpharmaceuticalreview
February 19, 2021
Targovax has announced its lead clinical candidate ONCOS-102 has received Fast-Track designation in malignant pleural mesothelioma from the U.S. Food and Drug Administration (FDA).
FDA Grants Emergency Use Authorization for COVID-19, Flu A, Flu B Combo Kit americanpharmaceuticalreview
February 19, 2021
The U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for the Applied Biosystems TaqPath COVID-19, Flu A, Flu B Combo Kit from Thermo Fisher Scientific.
Granules India gets US FDA approval for Potassium Chloride ER Capsules expresspharma
February 18, 2021
Potassium Chloride is indicated for the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxications, and in patients with hypokalemic familial periodic paralysis.
Lupin, Aurobindo recall drugs in US market expresspharma
February 18, 2021
Lupin Pharma is recalling 46,479 bottles of Oseltamivir Phosphate for Oral Suspension while AuroMedics Pharma, a unit of Aurobindo Pharma, is recalling 3,094 cartons of Acetaminophen injection.
Pfizer gets US FDA approval for PANZYGA to treat chronic inflammatory demyelinating polyneuropathy expresspharma
February 18, 2021
t is the only FDA-approved intravenous immunoglobulin with two maintenance dosing options for CIDP.

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