A Case Study in Pharmacopoeia Compliance: Excipients and Raw Materials

The company said that Vyvgart (efgartigimod alfa) is the first novel mechanism of action for CIDP treatment in more than 30 years.

In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.

The policy announced by Commissioner Martin A. Makary, MD, will not preclude employees of regulated companies from presenting their views to committees, and rare exceptions will be allowed.

In this episode, Alexander Natz from EUCOPE chats about the European Health Data Space.

Calculating the amount of drug needed for compounding requires different considerations for respective drug types and forms.

Vitrakvi (larotrectinib) was first granted accelerated approval by FDA in November 2018.