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Dr Reddy’s announces launch of Colchicine Tablets USP in the US
expresspharma
June 16, 2020
It is available in 0.6 mg tablets in bottle count sizes of 30s and 100s.
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Caplin Steriles gets USFDA approval for Phenylephrine Hydrochloride Injection USP
expresspharma
June 16, 2020
It is indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anaesthesia.
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Lupin voluntarily recalls a lot of diabetes drug in the US
expresspharma
June 16, 2020
An FDA analysis showed that this lot exceeded the acceptable daily intake limit for NDMA, an impurity that can cause cancer.
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FSD Receives FDA Approval to Design Trial for COVID-19 Treatment
americanpharmaceuticalreview
June 15, 2020
FSD Pharma announced the U.S. Food and Drug Administration (FDA) has given the company permission to submit an Investigational New Drug Application (IND) for the use of FSD-201 to treat COVID-19, the disease caused by the SARS-CoV-2 virus.
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AbbVie Submits Regulatory Applications to FDA, EMA for Psoriatic Arthritis Treatment
americanpharmaceuticalreview
June 15, 2020
AbbVie has submitted applications for a new indication to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for RINVOQ™ (upadacitinib; 15 mg, once daily), a selective and reversible JAK inhibitor ...
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RenovoRx Announces Orphan Drug Designation Granted for Treating Bile Duct Cancer
americanpharmaceuticalreview
June 15, 2020
RenovoRx announced the U.S. Food and Drug Administration (FDA) has granted the Company orphan drug designation for treating bile duct cancer, also known as cholangiocarcinoma, with intra-arterial gemcitabine.
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TVAX Biomedical Receives Fast Track Designation for Brain Cancer Treatment
americanpharmaceuticalreview
June 15, 2020
TVAX Biomedical announced receipt of Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the use of its vaccine-enhanced adoptive T cell therapy (VACT) for treatment of glioblastoma multiforme, a deadly form of brain cancer.
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FDA Approves Recarbrio
americanpharmaceuticalreview
June 15, 2020
The U.S. Food and Drug Administration (FDA) approved Recarbrio (a combination of imipenem-cilastatin and relebactam) to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) ...
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Novartis Announces Update on FDA Review of Ofatumumab
americanpharmaceuticalreview
June 15, 2020
Novartis has received notice from the US Food and Drug Administration (FDA) the agency has extended its review of the Supplemental Biologics License Application (sBLA) for ofatumumab (OMB 157) ...
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FDA approves drug to treat infants and children with HIV
expresspharma
June 15, 2020
The safety and effectiveness of Tivicay and Tivicay PD were supported by a trial that included 75 HIV-1–infected infants, children and adolescents four weeks to less than 18 years old.