Aldeyra received an FDA CRL for reproxalap, necessitating an additional study for DED approval. Read why I continue to rate ...
PTC Therapeutics' gene therapy is already approved in the European Union, Great Britain, and Israel. The drugmaker will also ...
A primary benefit of the FDA Fast Track designation is how it accelerates the drug approval process. Early and continuous ...
Secondary endpoints will include duration of response and overall survival. There are no fully FDA approved treatments for ...
That approval pathway is for devices that are similar to products that are already approved for market. GE HealthCare said the system would offer new capabilities in clinical imaging and neuroscience ...