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Rachael Harper (European Pharmaceutical Review)
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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.
Drug companies are still raising prices for brand-name prescription medicines but not as often or by as much as they used to.
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.
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.
In order keep up-to-date records and protect public health the FDA has announced it intends to deactivate out-of-date drug listings.
Lidocaine topical cream and liquid gel products are being recalled as the lidocaine amount is higher than the label states.
An Ebola clinical trial has been stopped early as Regeneron's REGN-EB3 therapy shows superiority to ZMapp in preventing Ebola deaths.
The US District Court has ruled in favour of Eli Lilly in the Alimta patent lawsuit against Dr. Reddy's Laboratories and Hospira, Inc.