The two pharmaceutical companies are facing a legal battle after Mylan filed a new drug application for a generic of Novo Nordisk’s Victoza.
List view / Grid view
US Food and Drug Administration (FDA)
Filter the results
Ningbo Huize Commodity Co has been sent a warning letter for cGMP violations, including data integrity issues.
A study has found that between 2014 and 2016, the EMA and FDA had very little divergence in their marketing authorisation decisions.
New research has found that of the 38 warning letters handed out by the FDA in 2019, the US and India received the vast majority.
An investigational Zika vaccine currently being evaluated in a Phase I study has been given a Fast Track designation by the FDA.
A warning letter has been sent to Emcure Pharmaceuticals after an FDA facility inspection found that the company did not adequately investigate sterility failures.
The FDA has accepted an IND application for AG017, a new drug designed to treat the causes of coeliac disease which will soon enter new trials.
The pharmaceutical company has received a complete response letter for its golodirsen injection, which had been submitted for accelerated approval.
The FDA has given its approval to RINVOQ for the treatment of active rheumatoid arthritis after the drug reached its endpoints in clinical trials.
Sanofi has won the latest appeal for the patent of its top oncology product, Jevtana (cabazitaxel).
Pfizer has volountarily recalled the migraine medication Relpax because of the potential presence of Pseudomonas and Burkholderia.
A complete response letter (CRL) has been sent to Dr Reddy’s for two generic products.
Pretomanid in combination with bedaquiline and linezolid has been approved by the FDA for treatment-resistant tuberculosis of the lungs.