European Pharmaceutical Review

JULY 4, 2024

In the US, botanical dietary supplements can be sold without US Food and Drug Administration (FDA) approval, 1 prompting many vendors to promote the use of botanical products as dietary supplements , 2 rather than pursue a path of regulatory approval. 3 Is two too few?

Marketing 103

Marketing Food and Drug Administration Medicine Prescription 103

European Pharmaceutical Review

AUGUST 11, 2023

Novartis said the decision to revoke the authorisation was based on a review of crizanlizumab under Article 20 of Regulation (EC) No 726/2004. Crizanlizumab is approved for use by the United States Food and Drug Administration (FDA). EMA required the STAND study as part of the marketing authorisation.

Marketing 98

Marketing Food and Drug Administration Medicine FDA 98

European Pharmaceutical Review

JANUARY 29, 2024

1 Some five years after the initial NDMA (N-nitrosodimethylamine) contamination issue 2 initially affecting valsartan drug substance, then other active pharmaceutical ingredients (APIs), eg, sartans, ranitidine, metformin, etc; the toxic short alkyl chain N-nitrosamine issue appears, if not resolved, then well on the way to resolution.

Pharmaceutical 111

Pharmaceutical Food and Drug Administration Medicine FDA 111

European Pharmaceutical Review

JUNE 24, 2022

RECENTLY, there has been a spate of withdrawals caused by nitrosamine drug substance-related impurities (NDSRIs). These NDSRIs can form during manufacturing or subsequent storage of the drug product. It has also outlined the various issues impacting on the drug product.

Food and Drug Administration 52

Food and Drug Administration Manufacturing Food FDA 52

European Pharmaceutical Review

MAY 11, 2023

Three SMN-enhancing treatments for the condition are approved by the US Food and Drug Administration (FDA) 2 , however there is no cure for SMA at present. This is often called an ‘SMN-based’ or ‘SMN-enhancing’ approach.

Food and Drug Administration 95

Food and Drug Administration Government Healthcare Healthcare 95

European Pharmaceutical Review

MARCH 7, 2024

Last month, construction began on Europe’s first industrial-scale facility dedicated to the production of lead-212 based radioligand therapies. Based on these promising results, the US Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to AlphaMedix in February 2024.

Manufacturing 52

Manufacturing Food and Drug Administration Marketing Management 52

European Pharmaceutical Review

JULY 5, 2022

Several lifestyle factors have been shown to increase the risk of developing stomach cancer, including alcohol consumption, smoking and consuming foods preserved by salts. There is an urgent need for more effective chemotherapy treatments with less severe toxicity and side effects. New hope for stomach cancer patients.

Patients 104

Patients Food and Drug Administration Side effects Safety 104