OR WAIT null SECS
December 21, 2018
The agency has approved Stemline Therapeutics’ Elzonris (tagraxofusp-erzs) infusion for the treatment of blastic plasmacytoid dendritic cell neoplasm for both adults and pediatric patients.
December 18, 2018
The company’s biosimiliar to Roche’s Avastin (bevacizumab) received a positive opinion for marketing authorization from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).
The agency sent a warning letter to Cao Medical Equipment Co., Ltd. after inspectors found CGMP violations at the company’s Langfang, Hebei facility.
December 13, 2018
FDA has withdrawn the proposed rule that would have allowed generic-drug makers to independently update and distribute new safety information in drug labels.
December 12, 2018
New FDA guidance developed to identify lapses in data integrity and promote best practices.
FDA cites Zhejiang Huahai Pharmaceutical in valsartan impurity investigation.
December 10, 2018
FDA has approved Truxima (rituximab-abbs), a biosimilar to Roche’s anti-cancer biologic, Rituxan (rituximab).
December 05, 2018
The EMA has published a revision to its guideline on the environmental risk assessment of human medicines.
December 03, 2018
The proposal from the Centers for Medicare and Medicaid Services (CMS) proposes to give plans more flexibility to limit coverage of certain drugs.
December 02, 2018
A required time frame should not be the driving force behind root cause investigations, says Susan Schniepp, executive vice-president of Post-Approval Pharma and Distinguished Fellow, Regulatory Compliance Associates.