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Lupin to approach USFDA for reinspection of key plants in next few months
expresspharma
June 15, 2020
Reportedly, regulatory action by the USFDA has impacted several new approvals, thus affecting the company's business in various regions including the US that remains the single-largest pharma market globally.
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US FDA seeks fast review of COVID-19 products: Commissioner Stephen Hahn
expresspharma
June 12, 2020
Since the onset of the COVID-19 pandemic earlier this year, the FDA has issued a series of temporary emergency approvals ranging from diagnostic tests to treatments such as Gilead Sciences’ antiviral drug remdesivir.
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Lupin receives US FDA’s approval for Albendazole Tablets USP
expresspharma
June 12, 2020
Albendazole Tablets USP, 200 mg, are an anthelmintic drug indicated for treatment of cystic hydatid disease of multiple organs and Parenchymal neurocysticercosis.
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US FDA grants approval of Uplizna to Viela Bio
expresspharma
June 12, 2020
Uplizna is the second FDA approved therapy for Neuromyelitis Optica Spectrum Disorder which offers patients additional treatment option.
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FDA Accepts sNDA with Priority Review for FETROJA
americanpharmaceuticalreview
June 11, 2020
Shionogi announced the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) for FETROJA® (cefiderocol) and granted Priority Review designation ...
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FDA Clears IND for iNKT Cells to Treat COVID-19 Patients
americanpharmaceuticalreview
June 11, 2020
Agenus announced the U.S. Food and Drug Administration’s (FDA) clearance of AgenTus' IND application for an allogeneic iNKT therapy.
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FDA Approves Atezolizumab, plus Bevacizumab for Unresectable Hepatocellular Carcinoma
americanpharmaceuticalreview
June 11, 2020
The Food and Drug Administration (FDA) has approved atezolizumab in combination with bevacizumab (TECENTRIQ and AVASTIN, Genentech Inc.) for patients with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy.
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FDA Announces Alert of Amneal, Impax Epinephrine Auto-Injector Malfunctions
americanpharmaceuticalreview
June 11, 2020
FDA is alerting patients, caregivers and health care professionals to immediately inspect certain lots of Amneal and Impax epinephrine auto-injector 0.3 mg to ensure the yellow “stop collar” in the device is present.
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Phosphorus Announces FDA Approval Of At-Home Saliva Test For COVID-19
prnewswire
June 09, 2020
At-Home Saliva Test Gains Federal Approval After Rigorous Round of Validation Studies.
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FDA Updates Q&A Appendix of Medical Products During COVID-19 Public Health Emergency
americanpharmaceuticalreview
June 09, 2020
The U.S. Food and Drug Administration (FDA) added content to the question-and-answer appendix in its guidance titled “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency.”