Shots:
The US FDA approved 6 NDAs and 4 BLA in April 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 36 novel products in 2023
In April 2023, the major highlights drugs were, Trikafta approval for children with cystic fibrosis, Qalsody for the treatment of amyotrophic…
Shots:
Volker spoke about the granting of marketing authorization by EC to treat adults with active lupus nephritis.The approval was based on the results of the P-III AURORA study
Volker also talked about the collaboration between Aurinia and Otsuka Pharmaceutical for the development and commercialization of LUPKYNIS
The interview gives an understanding of how Aurinia…
The US FDA has approved multiple NDAs and BLAs in July 2020, leading to treatments for patients and advances in the health care industry. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 59 novel products so far in 2020, including 8 in July 2020. Additionally,…

