FDA Approvals

Revance Therapeutics may soon run into an identity problem with a product that is so eagerly awaited that some people...

For intravenous infusion in paediatric and adult patients with Acid Sphingomyelinase Deficiency (ASMD), a rare genetic disorder that results in...

According to a study of the reasons behind warning letters sent by the US Food and Drug Administration Center for Drug Evaluation...

Priority consideration has been given to AstraZeneca's supplemental new drug application for Lynparza (olaparib) when used in conjunction with abiraterone,...

Gene therapy for blood disorders developed by Bluebird Bio has already left the nest in the US. Zynteglo, sometimes known...

While a large portion of the biopharma industry prepares for a battle over medication prices, Bayer is getting ready for...

Gilead staked money on Trodelvy providing a life-extension benefit when it failed to show promise in halting tumour development in...

With two significant FDA clearances in as many weeks, Enhertu from AstraZeneca and Daiichi Sankyo is blazing. On August 11th,...

Although Pfizer beat Merck to sell its next-generation pneumococcal vaccination, it lost a more important battle in June when the...

The pharmaceutical lobbying group's aura of invincibility has faded. The U.S. Senate recently passed a new bill, leaving the pharmaceutical...