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Alembic Pharmaceuticals receives US FDA’s tentative approval for Empagliflozin and Metformin Hydrochloride Tablets
expresspharma
July 21, 2020
The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Synjardy Tablets of Boehringer lngelheim Pharmaceuticals.
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Patheon to Manufacture FDA-Approved Nasal Spray
contractpharma
July 20, 2020
Evoke Pharma initiates commercial manufacturing of Gimoti with the CDMO.
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We are monitoring sale, supply of medicines for COVID-19 treatment: Haryana FDA
expresspharma
July 20, 2020
Haryana Medical Services Corporation (HMSC) has procured 400 vials of remdesivir and tocilizumab from Cipla to ensure availability of key drugs.
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Zydus Cadila gets US FDA nod to market generic tension headache tablets
expresspharma
July 20, 2020
The drug will be manufactured at Nesher Pharma’s manufacturing facility at St Louis in the US.
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Common FDA-approved drug may effectively neutralize virus that causes COVID-19
worldpharmanews
July 17, 2020
A common drug, already approved by the Food and Drug Administration (FDA), may also be a powerful tool in fighting COVID-19, according to research published this week in Antiviral Research.
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CorMedix Submits Defencath New Drug Application
americanpharmaceuticalreview
July 17, 2020
CorMedix announced all of the modules for the Defencath™ New Drug Application (NDA) have been submitted to the Food and Drug Administration (FDA).
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FDA Approves Decitabine, Cedazuridine Oral Combination for MDS
americanpharmaceuticalreview
July 17, 2020
The Food and Drug Administration (FDA) approved an oral combination of decitabine and cedazuridine (INQOVI, Astex Pharmaceuticals, Inc.) for adult patients with myelodysplastic syndromes (MDS) including the following.
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US FDA working to restart on-site inspections during week of July 20
expresspharma
July 17, 2020
The FDA, which is working towards resuming on-site inspections around July 20, also determined that, for the foreseeable future, prioritized domestic inspections will be pre-announced to FDA-regulated businesses.
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FDA committee backs GSK's multiple myeloma drug
pharmatimes
July 15, 2020
GlaxoSmithKline's belantamab mafodotin has been backed for approval to treat relapsed/refractory multiple myeloma by the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC).
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Several Companies Voluntarily Recall Extended Release Metformin
americanpharmaceuticalreview
July 15, 2020
The U.S. Food & Drug Administration (FDA) is alerting patients and health care professionals to several voluntary recalls of extended release (ER) metformin by the companies listed below.