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Clearside Biomedical received a complete response letter (CRL) from the FDA for its macular edema drug candidate over the need for additional stability data. Read More
The EMA’s Committee for Medicinal Products for Human Use (CHMP) endorsed seven drugs for approval at its October meeting, including a biosimilar of Amgen’s Neulasta (pegfilgrastim). Read More
Acting FDA Commissioner Ned Sharpless announced that the agency once again approved a record number of generic drugs in fiscal 2019 and flagged upcoming actions to maintain the upward trend. Read More
The FDA on Tuesday unveiled its first joint approval for oncology drugs with regulators in Australia and Canada under an initiative called Project Orbis, granting accelerated approval for a combination treatment for advanced endometrial cancer. Read More
The FDA has again shot down Mylan and Biocon’s copycat of Sanofi’s Lantus (insulin glargine) with a complete response letter, pending the completion of corrective actions at Biocon’s Malaysian insulin plant. Read More
A study by the FDA and EMA comparing their decisions on drug marketing applications found the two agencies align in most cases — but sometimes reach different conclusions about a drug’s efficacy. Read More
The FDA on Thursday approved Genentech’s Rozlytrek (entrectinib) for adults and adolescents who have cancers with a common biomarker — only the third time the agency has approved a cancer treatment on the basis of a biomarker rather than for treatment of a specific tumor. Read More