PTC Therapeutics' gene therapy is already approved in the European Union, Great Britain, and Israel. The drugmaker will also ...
Save the addition of salt, spices and other add-ins for taste, butter is a single-ingredient food. So, it may come as a ...
Investors and entrepreneurs will track decisions affecting drugs, medical devices and telehealth.
Many seriously ill people die waiting for the FDA to approve drugs that regulators in other advanced countries have already ...
Aldeyra received an FDA CRL for reproxalap, necessitating an additional study for DED approval. Read why I continue to rate ...
Following strong treatment response data for Adaptimmune’s lete-cel, the biotech is planning to initiate a rolling BLA ...
Last month, the U.S. Food and Drug Administration (FDA) recalled almost 80,000 pounds of Costco's popular store-brand butter ...
It’s hard to watch the news or scroll through social media without encountering stories about weight loss drugs like ...
The FDA’s proposal comes more than a year after its outside advisers voted against the continued use of oral phenylephrine, ...
FOX 2 - You know what season we're about to enter? The season of sniffling, sneezing and sinus trouble. But now the FDA is ...
Of those who have fallen ill, 34 were hospitalized; four people developed HUS, a condition that causes kidney failure; and ...
The FDA Modernization Act of 1997 established the Fast Track designation to expedite developing and reviewing new drugs ...