Fast Track designation given to heart failure treatment
Farxiga (dapagliflozin) has been given Fast Track designation by the FDA to reduce the risk of cardiovascular death.
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Farxiga (dapagliflozin) has been given Fast Track designation by the FDA to reduce the risk of cardiovascular death.
Nucala is the first biologic approved in the US for six- to 11-year-old children with severe eosinophilic asthma by the FDA.
The EMA and the FDA are investigating some ranitidine medicines after they were found to contain NDMA, a probable human carcinogen.
The FDA says that even though it recognises the importance of compounded drugs, they also pose a risk to patient safety.
GVOKE injection has received regulatory approval from the FDA for the treatment of severe hypoglycemia in patients with diabetes.
Orphan Drug Designation has been given to sotatercept for the treatment of patients with pulmonary arterial hypertension.
Tepotinib, an investigational therapy for patients with metastatic non-small cell lung cancer has been given Breakthrough Therapy Designation.
Bacteriostatic Water is being recalled because of a lack of sterilisation confirmation for some vials.
Both the intravenous and oral formulations of the antifungal candidate, fosmanogepix, have been granted Fast Track designation by the FDA.
Two Tennessee companies have been prevented from distributing drugs after a complaint they were supplying unapproved medications.
The FDA has approved the first treatment for interstitial lung disease associated with systemic sclerosis or scleroderma.
Generic treatments for blood/bone marrow disorders and acute nausea and vomiting associated with chemotherapy have gained FDA approval.
The biologic treatment ustekinumab has been granted an expanded use for ulcerative colitis within the EU.
The FDA has awarded a breakthrough therapy designation to an investigational prophylactic vaccine to treat respiratory syncytial virus in seniors.
The Joint Pharmaceutical Analysis Group (JPAG) held a stability meeting at the Royal Society of Chemistry’s headquarters in London earlier this year. Attended by 65 delegates, its focus was on developments in stability testing and evaluation. Here follows a summary of the presentations made at the meeting.