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 ...

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 ...

The FDA’s openness to a pathway for accelerated approval using biomarker-based endpoints, such as caudate atrophy, supports the potential for WVE-003 to progress rapidly through clinical trials.

our ability to work with our third-party contract manufacturing organization ("CMO") and the FDA to adequately address the issues raised in the CRL and execute on a pathway forward for the potential ...

“We also announced that the FDA has approved our IDE application allowing us to move ... InspireMD’s common stock is quoted on the Nasdaq under the ticker symbol NSPR. We routinely post information ...

REDWOOD CITY, Calif., Nov. 06, 2024 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (Coherus or the Company, Nasdaq: CHRS), today reported financial results for the quarter ended September 30, 2024 and ...

Unicycive, which is seeking an FDA green light for oxylanthanum carbonate to treat hyperphosphatemia in patients with chronic kidney disease who are on dialysis, Monday said the agency set a target ...

FDA approves Autolus Therapeutics' Aucatzyl for adults with relapsed or refractory B-cell precursor acute lymphoblastic ...