PHOENIXVILLE, PA — Facet Life Sciences, a firm specializing in regulatory guidance for life science companies, has announced ...

The drugs we use as prescribed by doctors represent the product approved by the FDA for a specified medical use under its NDA or BLA. Let’s take a look at some of the technical definitions ...

Islamabad: The Baloch Liberation Army (BLA) is planning to intensify its fight against the Pakistani government and army. BLA, which shook the entire world by hijacking the Jaffer Express in ...

Further, Table 3 identifies device product codes (procodes) for device constituent parts of Abbreviated New Drug Application (ANDA), New Drug Application (NDA) and Biological License Application (BLA) ...

Natco Pharma has submitted abbreviated new drug application (ANDA) for Risdiplam for oral solution, a generic version of Genentech Inc’s spinal muscular atrophy drug Evrysdi (Risdiplam ...

However, in the case of BLA, once the application is approved, the Sponsor is granted a license for the biological drug; this licensing process is not a part of the NDA. A new drug application (NDA) ...

To speed up drug applications, the FDA has laid out new guidance on how to request a platform designation that can smooth subsequent applications for biotechs working off the same reproducible ...

2024年2月，vorasidenib的上市申请（NDA）获FDA受理并授予优先审评 ... 维昇/ Ascendis的注射用隆培促生长素的上市许可申请（BLA）获CDE受理。

Abbreviated New Drug Application (ANDA) Over-the-Counter Drugs (OTC) Biologic License Application (BLA) Receiving any one of these approvals or designations can have a significant impact on a ...