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The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has called for revoking the marketing authorizations of Esmya (ulipristal acetate) and its generics for uterine fibrosis after confirming the drug can cause serious liver injuries. Read More
Sanofi and GlaxoSmithKline announced in Security Exchange Commission (SEC) filings that the Department of Justice and the U.S. Attorney’s Office for the Eastern District of Pennsylvania have opened an investigation into their reporting of potentially contaminated Zantac (ranitidine). Read More
Type 2 Diabetes drug metformin is the latest medicine to be recalled due to unacceptable levels of the probable human carcinogen NDMA (N-Nitrosodimethylamine). Read More
The FDA said it found unacceptable levels of NDMA (N-Nitrosodimethylamine) in extended-release versions of the type 2 diabetes drug metformin. Read More
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) called for new product information for hormone replacement therapy (HRT) to reflect the risk of breast cancer. Read More
A California appeals court has ruled that hundreds of Risperdal-related cases against Johnson & Johnson and its subsidiaries may proceed, reversing a decision that had dismissed the pending cases. Read More
In a reversal for the agency, the FDA called for the immediate withdrawal of all ranitidine products from the U.S. market due to N-Nitrosodimethylamine (NDMA) contamination. Read More