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FDA Issues Policies to Guide Medical Product Developers Addressing Virus Variants americanpharmaceuticalreview
February 23, 2021
The U.S. Food and Drug Administration (FDA) has issued guidances for medical product developers, specifically covering vaccines, diagnostics and therapeutics products, to address the emergence and potential future emergence of variants of SARS-CoV-2 ...
FDA Approves Evkeeza americanpharmaceuticalreview
February 22, 2021
Regeneron Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) approved EvkeezaTM (evinacumab-dgnb) as an adjunct to other low-density lipoprotein cholesterol (LDL-C) lowering therapies to treat adult and pediatric patients aged 12 ...
Catapult Receives FDA Clearance of IND for Humanized Anti-CCR7 Antibody americanpharmaceuticalreview
February 22, 2021
Catapult Therapeutics has announced the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for its lead product candidate CAP-100, an innovative first-in-class humanized anti-CCR7 antibody for treatment ...
FDA Approves Drug to Reduce Bone Marrow Suppression Caused by Chemotherapy americanpharmaceuticalreview
February 22, 2021
The U.S. Food and Drug Administration (FDA) approved Cosela (trilaciclib) as the first therapy in its class to reduce the frequency of chemotherapy-induced bone marrow suppression in adults receiving certain types of chemotherapy for extensive-stage ...
Unichem Laboratories gets USFDA approval for Apremilast Tablets expresspharma
February 20, 2021
Unichem Laboratories has received ANDA approval for its Apremilast Tablets, 10 mg, 20 mg and 30 mg from the United States Food and Drug Administration (USFDA) to market a generic version of Amgen’s Otezla (apremilast) Tablets, 10 mg, 20 mg, and 30 mg.
Zydus Cadila gets final nod from USFDA for Droxidopa Capsules expresspharma
February 20, 2021
Zydus Cadila has received final approval from the USFDA to market Droxidopa Capsules, 100 mg, 200 mg, and 300 mg (US RLD: Northera Capsules).
Lupin gets US FDA approval for Droxidopa Capsules expresspharma
February 20, 2021
Lupin announced that it has received approval for its Droxidopa Capsules, 100 mg, 200 mg, and 300 mg, from the United States Food and Drug Administration, to market a generic equivalent of Northera Capsules, 100 mg, 200 mg, and 300 mg, of Lundbeck.
Aurobindo Pharma receives USFDA nod for Droxidopa Capsules expresspharma
February 20, 2021
Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Droxidopa Capsules, 100 mg, 200 mg and 300 mg. Droxidopa Capsules are generic version of Lundbeck’s Northera Capsules.
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.

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