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FDA Approves Therapy for Disease that Causes Low Phosphate Blood Levels, Bone Softening
americanpharmaceuticalreview
June 30, 2020
The U.S. Food and Drug Administration (FDA) has approved Crysvita (burosumab-twza) injection to treat patients age two and older with tumor-induced osteomalacia (TIO).
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FDA announces first of its kind pilot program to communicate patient reported outcomes from cancer clinical trials
worldpharmanews
June 29, 2020
The U.S. Food and Drug Administration launched Project Patient Voice, an initiative of the FDA’s Oncology Center of Excellence (OCE).
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FDA Approves Lyumjev
americanpharmaceuticalreview
June 29, 2020
The U.S. Food and Drug Administration (FDA) has approved Lyumjev™ (insulin lispro-aabc injection, 100 units/mL and 200 units/mL), Eli Lilly and Company's new rapid-acting insulin indicated to improve glycemic control in adults with type 1 and ...
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Valeo Pharma Receives FDA Approval for Ethacrynate Sodium
americanpharmaceuticalreview
June 29, 2020
Valeo Pharma has received approval for its Abbreviated New Drug Application (ANDA) from the U.S. Food and Drug Administration (FDA) for Ethacrynate Sodium 50 mg.
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FDA Grants Accelerated Approval Metastatic Small Cell Lung Cancer Treatment
americanpharmaceuticalreview
June 29, 2020
The Food and Drug Administration (FDA) has granted accelerated approval to lurbinectedin (ZEPZELCA, Pharma Mar S.A.) for adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.
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FDA Warns Four Manufacturers of Unapproved Injectable Drugs Labeled as Homeopathic
americanpharmaceuticalreview
June 29, 2020
The U.S. Food and Drug Administration (FDA) has issued warning letters to four companies for selling unapproved injectable drug products labeled as homeopathic that can pose serious risks to patient health and violate federal law ...
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Cosentyx Receives FDA Approval for New Indication
americanpharmaceuticalreview
June 29, 2020
Novartis announced the US Food and Drug Administration (FDA) has approved Cosentyx® (secukinumab) for the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA).
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Aethlon Announces FDA Approval of IDE Supplement for COVID-19 Patients
americanpharmaceuticalreview
June 29, 2020
Aethlon Medical announced the U.S. Food and Drug Administration (FDA) has approved a supplement to the Company's existing Investigational Device Exemption (IDE) for the Company's Hemopurifier® in viral disease to allow for the testing of ...
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FDA Revokes Emergency Use Authorization for Chembio Antibody Test
americanpharmaceuticalreview
June 29, 2020
The U.S. Food and Drug Administration (FDA) has revoked the emergency use authorization (EUA) of the Chembio Diagnostic System DPP COVID-19 IgM/IgG System ...
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FDA Approves Pembrolizumab for TMB-H Solid Tumors
americanpharmaceuticalreview
June 28, 2020
The Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (KEYTRUDA, Merck) for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) ...