Welcome to the Vistagen Therapeutics Fiscal ... but also Dr. Prasad said it from the CBER voice which is that no FDA reviewer or inspector was involved with the reduction in force, and that ...

The agency is strong. And my job is to make sure that every scientist, inspector, and law enforcement official at the FDA has all the resources they need to do their job well.” Makary also said ...

Please provide your email address to receive an email when new articles are posted on . Tezepelumab has received an FDA breakthrough therapy designation as a maintenance treatment for patients ...

Otsuka and Click Therapeutics’ Rejoyn has become the first prescription digital therapeutic (DTx) to be approved by the FDA for people with major depressive disorder. Rejoyn (formerly CT-152), a ...

At its second attempt, Astellas has won FDA approval for its first-in-class cancer therapy, Vyloy, which got the green light for certain gastric cancers. The US regulator approved Vyloy ...

After receiving the notice, an inspector came to her home to determine whether it was insurable. The result of the inspection? The inspector informed Nelms that she needed to replace her roof to ...