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August 30, 2019
EMA issued its recommendations surrounding the dosing of methotrexate in the treatment of inflammatory diseases, such as rheumatoid arthritis, psoriasis, and Crohn’s disease.
August 29, 2019
While downgrading the impact of nitrosamine impurities on patients, FDA vows to step up investigations for other drug types.
August 26, 2019
The supplemental new drug application seeks to add an indication for men with prostate cancer that has spread but is sensitive to hormone therapy.
August 21, 2019
FDA sent a warning letter to NingBo Huize Commodity Co. after an investigation of the company’s Zhejiang facility found falsified quality documents.
August 20, 2019
FDA has approved Regeneron Pharmaceuticals’ Eylea (aflibercept), an anti-vascular endothelial growth factor inhibitor, to treat four retinal conditions.
The US Pharmacopeial Convention is proposing a policy change to the inclusion of reporting thresholds in drug substance and drug product monographs.
The agency approved Xenleta (lefamulin) to treat adults with community-acquired bacterial pneumonia.
FDA has issued a complete response letter to Sarepta Therapeutics for its new drug application seeking approval for a new Duchenne muscular dystrophy drug.
August 19, 2019
The new drug is meant to be used in combination therapy for treating pediatric patients with pulmonary multidrug-resistant tuberculosis.
FDA has approved Roche’s new cancer drug for treating metastatic non-small cell lung cancer and NTRK gene fusion-positive solid tumors and neurotrophic tyrosine receptor kinase gene fusion-positive solid tumors.