Investigational Zika vaccine receives Fast Track designation
An investigational Zika vaccine currently being evaluated in a Phase I study has been given a Fast Track designation by the FDA.
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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.
Pfizer has volountarily recalled the migraine medication Relpax because of the potential presence of Pseudomonas and Burkholderia.
A leaked government dossier has stated that in the event of a no-deal Brexit, the UK will face severe medicinal shortages.
SGS Life Sciences launches OneVision, a global digitalisation initiative to create a single, integrated network of testing laboratories.
An MHRA consultation is due to end on 31 August, with public comments on AQbD principles closing soon.
The cancer therapeutic, Rozlytrek, has gained FDA approval as well as Priority Review, Breakthrough Therapy and Orphan Drug Designations.
Researchers have developed silica spheres to contain cancer therapeutics that melt at certain temperatures and have the potential to improve drug delivery.
A complete response letter (CRL) has been sent to Dr Reddy’s for two generic products.
The DHSC has confirmed that several pharmaceutical industry bodies have agreed to NDAs regarding plans for a no-deal Brexit.