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September 02, 2019
Providing regulators with a holistic approach to addressing deficiencies is the best response to an inspection, says Siegfried Schmitt, PhD, vice-president, technical, Parexel Consulting.
September 01, 2019
Industry experts discuss the challenges and regulations of setting up a CGMP-compliant stability testing program.
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 23, 2019
Joint analysis from the EMA and the US FDA has shown that the regulatory bodies are highly aligned in the majority of marketing authorization decisions.
GSK has submitted a Japanese New Drug Application (JNDA) for its oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), daprodustat.
A biosimilar to Eli Lilly’s Forsteo, biosimilar teriparatide, has been launched across Europe by Gedeon Richter following the patent expiration of the reference product.
August 20, 2019
The agency approved Xenleta (lefamulin) to treat adults with community-acquired bacterial pneumonia.
August 16, 2019
FDA sent a warning letter to Emcure Pharmaceuticals, Ltd. because of sterility testing CGMP violations.
August 15, 2019
The European Commission has approved an extension of the use of Dupixent (dupilumab) within the EU to include patients aged 12 to 17 years old with moderate-to-severe atopic dermatitis.