You are here: Industry Insights > FDA

News List

FDA approves sNDA for candidiasis treatment in paediatric patients europeanpharmaceuticalreview
January 13, 2020
Supplemental new drug application (sNDA) has been approved for an expanded indication of MYCAMINE® for the treatment of invasive candidiasis in paediatric patients under four months old.
FDA approves Ayvakit, the first targeted gastrointestinal stromal tumour treatment europeanpharmaceuticalreview
January 13, 2020
The US Food and Drug Administration (FDA) has approved the kinase inhibitor Ayvakit (avapritinib) for the treatment of unresectable or metastatic gastrointestinal stromal tumours (GIST) harbouring platelet-derived growth factor receptor alpha (PDGFRA) exo
FDA approves Astellas’ Mycamine supplemental new drug application pharmaceutical-technology
January 13, 2020
The US Food and Drug Administration (FDA) has approved Astellas Pharma’s supplemental New Drug Application (sNDA) for Mycamine (micafungin for injection).
Blueprint Medicines secures FDA approval for Ayvakit pharmaceutical-technology
January 13, 2020
Blueprint Medicines has secured the US Food and Drug Administration (FDA) approval for Ayvakit (avapritinib) for treating unresectable or metastatic gastrointestinal stromal tumour among adults (GIST).
AstraZeneca’s Farxiga gets FDA priority review for heart failure with HFrEF pharmaceutical-business-review
January 09, 2020
AstraZeneca’s Farxiga (dapagliflozin) has been granted priority review from the US Food and Drug Administration (FDA) for a certain population of patients with heart failure.
FDA Approves Pembrolizumab for Bladder Cancer americanpharmaceuticalreview
January 09, 2020
The Food and Drug Administration (FDA) approved pembrolizumab (KEYTRUDA, Merck) for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk ...
FDA announces new centre to improve compounded drug quality europeanpharmaceuticalreview
January 09, 2020
A new centre has been established by the FDA that will allow the agency to improve the quality and safety of compounded drugs by providing educational programmes to outsourcing facilities.
Acute myeloid leukemia treatment receives FDA Orphan Drug Designation europeanpharmaceuticalreview
January 09, 2020
Orphan drug designation has been approved by the FDA for PRGN-3006 UltraCAR-T™ for patients with acute myeloid leukemia (AML).
FDA approves Novo Nordisk’s Fiasp for diabetic children pharmaceutical-technology
January 09, 2020
Danish pharmaceutical company Novo Nordisk has secured US Food and Drug Administration (FDA) approval for Fiasp as a mealtime insulin option for diabetic children.
Farxiga granted FDA Priority Review for patients with heart failure with reduced ejection fraction worldpharmanews
January 07, 2020
AstraZeneca announced the US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) and granted Priority Review for Farxiga (dapagliflozin) to reduce the risk of cardiovascular (CV) death or the worsening of heart failu

Previous page 1 2 3 4 5 6 7 8 9 10 ... 366 367 Next page