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 ...

Change of the Company’s corporate name to Grace Therapeutics, Inc. The Company’s common stock commenced trading under the trading symbol “GRCE” on Nasdaq ... (A-T), for which there are currently no ...

Clene met with the U.S. Food and Drug Administration (FDA) on November 1, 2024, in a Type C meeting to discuss the potential for an accelerated approval pathway in ALS ... and the Company’s existing ...

The FDA has granted Jan123 Orphan ... and its Nasdaq ticker symbol was updated to ALTS. On August 26, 2024, the Company appointed Peter Tassiopoulos as CEO. In October, the Board approved the ...

The Company has received approval to list its common shares on the Nasdaq Capital Market under the symbol “ACOG” and is ...

ReShape Lifesciences® (Nasdaq: RSLS), the premier physician-led weight loss and metabolic health solutions company, today announced that Health Canada ...

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 ...

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 ...

TRV045 is an investigational product and is not yet approved by the FDA. Subjects in both studies referenced in this press release were enrolled outside of the United States, and the studies were not ...