OTC drug manufacturer receives warning letter for data integrity issues
Ningbo Huize Commodity Co has been sent a warning letter for cGMP violations, including data integrity issues.
List view / Grid view
Ningbo Huize Commodity Co has been sent a warning letter for cGMP violations, including data integrity issues.
A late-stage clinical trial for Imfinzi and an experimental treatment has not extended the lives of patients with advanced non-small cell lung cancer.
A study has found that between 2014 and 2016, the EMA and FDA had very little divergence in their marketing authorisation decisions.
The US HHS has committed to a contribution to help Merck manufacture its investigational V920 vaccine for the treatment of Ebola.
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.
A new biosimilar drug to treat osteoporosis is now available across Europe after the patent for its reference product expired.
Drug companies are still raising prices for brand-name prescription medicines but not as often or by as much as they used to.
Brüün has announced he will be leaving his role as CEO at the BPS and moving to a new role at the Royal College of Anaesthetists.
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).
The worldwide trade of the cephalosporin class of antibiotics will increase to $14.1 billion by the end of 2025.