We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The drugmaker said it believes that the issues in the complete response letter “can be addressed in a timely manner” to enable the company to resubmit the NDA in the first quarter of 2020. Read More
Biogen has decided to renew its bid for FDA approval in early 2020 of its investigational anti-amyloid Alzheimer’s drug aducanumab after halting clinical trials earlier this year. Read More
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