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 ...

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) ...

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) ...

Hyderabad: Natco Pharma Ltd has submitted an abbreviated new drug application (ANDA) containing a Paragraph IV certification for a generic version of migraine drug Rimegepant Sulfate table 75mg ...

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 ...