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First oral GLP-1 treatment for type 2 diabetes approved
With the approval of the treatment, Rybelsus, there is a new option for treating type 2 diabetes without injections.
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US Food and Drug Administration (FDA)
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Two lots of quinacrine recalled due to labelling error
Darmerica LLC is voluntarily recalling two lots of quinacrine dihydrochloride due to a label mix-up.
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FDA accepts Biologics License Application for V920 Ebola vaccine
A Biologics License Application and priority review has been approved by the FDA for an investigational Ebola vaccine.
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Company sues FDA over rejecting opioids intended to deter abuse
Pharmaceutical Manufacturing Research Services has filed a lawsuit against the FDA after it rejected its application for opioids with updated labelling and appearance, meant to discourage misuse.
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Collaborative oncology drugs review initiative announced by FDA
A new initiative has already collaboratively reviewed applications for two oncology drugs, allowing for simultaneous decisions in three countries.
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Multiple myeloma treatment granted Orphan Drug Designation
Orphan Drug Designation has been given to bispecific antibody candidate, GBR 1342, for the treatment of multiple myeloma.
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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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Treatment approved for young children with severe eosinophilic asthma
Nucala is the first biologic approved in the US for six- to 11-year-old children with severe eosinophilic asthma by the FDA.
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NDMA discovered in samples of ranitidine medicines
The EMA and the FDA are investigating some ranitidine medicines after they were found to contain NDMA, a probable human carcinogen.
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FDA emphasises need for adverse event reporting of compounded drugs
The FDA says that even though it recognises the importance of compounded drugs, they also pose a risk to patient safety.
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FDA grants regulatory approval for hypoglycemia treatment
GVOKE injection has received regulatory approval from the FDA for the treatment of severe hypoglycemia in patients with diabetes.
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FDA grants Orphan Drug Designation to sotatercept
Orphan Drug Designation has been given to sotatercept for the treatment of patients with pulmonary arterial hypertension.
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Metastatic NSCLC therapy, tepotinib, given Breakthrough Designation
Tepotinib, an investigational therapy for patients with metastatic non-small cell lung cancer has been given Breakthrough Therapy Designation.
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Bacteriostatic Water recalled due to a potential lack of sterility assurance
Bacteriostatic Water is being recalled because of a lack of sterilisation confirmation for some vials.
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Fast Track designation granted to fosmanogepix for seven indications
Both the intravenous and oral formulations of the antifungal candidate, fosmanogepix, have been granted Fast Track designation by the FDA.
