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FDA/Panel Decisions

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AstraZeneca (AZN.L, AZN) said Calquence (acalabrutinib), a monotherapy treatment for adult patients with chronic lymphocytic leukaemia, has been granted Breakthrough Therapy Designation by the FDA. The FDA decision was based on the positive results from the interim analyses of the ELEVATE-TN and ASCEND...

Biotechnology company Regeneron Pharmaceuticals, Inc. (REGN) announced Tuesday that the U.S. Food and Drug Administration (FDA) has approved the Chemistry, Manufacturing and Controls (CMC) Prior-Approval Supplement (PAS) for the EYLEA (aflibercept) Injection prefilled syringe. The 2 mg, single-dose,...

Sanofi (SNYNF, SNY) and Regeneron Pharmaceuticals Inc. (REGN) said Tuesday that the European Commission extended the marketing authorization for Dupixent or dupilumab in the European Union to include adolescents 12 to 17 years of age with moderate-to-severe atopic dermatitis who are candidates for systemic...

AstraZeneca plc (AZN.L, AZN) announced Monday that the European Commission has approved an update to the marketing authorisation for Forxiga (dapagliflozin). The label update will include positive cardiovascular or CV outcomes and renal data from the Phase III DECLARE-TIMI 58 trial in adults with type-2...

Janssen Pharmaceutical Companies of Johnson & Johnson (JNJ) said that that the European Medicines Agency's Committee for Medicinal Products for Human Use or CHMP has adopted a positive opinion recommending Stelara or ustekinumab's marketing authorization in the European Union for the treatment of adult...

lilly-july25.jpg Until yesterday, the treatment of severe hypoglycemia was a glucagon injection that involves a clunky and complicated system. Today, with FDA approving the glucagon nasal powder Baqsimi from Eli Lilly (LLY), patients with severe hypoglycemia can breathe a little easier.

CTI BioPharma Corp. (CTIC) said Thursday that it has completed a Type B, End-of-Phase-2a meeting with the U.S. Food and Drug Administration for the continued development of its investigational myelofibrosis treatment candidate, pacritinib. Following this meeting, CTI now plans to evaluate 200 mg of...

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