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FDA nod for Kiniksa’s Arcalyst in recurrent pericarditis pharmatimes
March 22, 2021
The US Food and Drug Administration (FDA) has approved Kiniksa Pharmaceuticals’ interleukin-1 alpha (IL-1α) and interleukin-1 beta (IL-1β) inhibitor Arcalyst (rilonacept) for the treatment of recurrent pericarditis and reduction in risk of recurrence ...
FDA Releases Updated Essure Report americanpharmaceuticalreview
March 22, 2021
The U.S. Food and Drug Administration (FDA) posted the seventh spreadsheet of reportable adverse events that Bayer is required to submit as outlined in the April 24, 2020 variance from MDR reporting requirements.
FDA Warns of Potential False Results with Roche Molecular Systems for COVID, Flu Test americanpharmaceuticalreview
March 22, 2021
The U.S. Food and Drug Administration (FDA) is alerting clinical laboratory staff, point-of-care (POC) facility staff, and health care providers that false positive results can occur with the Roche Molecular Systems, Inc. (Roche) cobas SARS-CoV-2 & ...
MRIGlobal Research Part Of First COVID-19 Test Approved For At-Home Use Without A Prescription prnewswire
March 22, 2021
MRIGlobal played a key role in achieving approval for the first SARS-CoV-2 diagnostic molecular test authorized for consumer at-home use without a prescription.
Nuvation Bio Granted Orphan Drug Designation for NUV-422 for Malignant Gliomas americanpharmaceuticalreview
March 19, 2021
Nuvation Bio announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to NUV-422, a cyclin-dependent kinase (CDK) 2/4/6 inhibitor, for the treatment of patients with malignant gliomas.
Lomecel-B Approved for Compassionate Use for Child with Hypoplastic Left Heart Syndrome americanpharmaceuticalreview
March 19, 2021
Longeveron announced the U.S. Food & Drug Administration (FDA) has granted expanded access approval for the administration of Longeveron’s investigational cell therapy Lomecel-B to a child with Hypoplastic Left Heart Syndrome (HLHS).
Priority review for Merck & Co’s belzutifan in rare kidney cancer subset pharmatimes
March 18, 2021
Merck & Co has received a priority review from the US Food and Drug Administration (FDA) for its potential rare kidney cancer treatment belzutifan.
Denali Announces Fast Track Designation to DNL310 for Hunter Syndrome americanpharmaceuticalreview
March 18, 2021
Denali Therapeutics announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ETV:IDS (DNL310) for the treatment of patients with Hunter syndrome (MPS II).
FDA Approves Tivozanib for Relapsed/Refractory Advanced Renal Cell Carcinoma americanpharmaceuticalreview
March 18, 2021
The U.S. Food and Drug Administration (FDA) approved tivozanib (Fotivda, AVEO Pharmaceuticals), a kinase inhibitor, for adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.
USFDA extends review period for AbbVie’s sNDA of upadacitinib pharmaceutical-business-review
March 18, 2021
The US Food and Drug Administration (FDA) has extended the review period for AbbVie’s supplemental New Drug Application (sNDA) for upadacitinib.

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