The FDA has released an “initial batch“ of more than 200 complete response letters (CRLs) in efforts to boost transparency. | ...

Even though the Gates family has no current involvement in Apeel, they’ve significantly financed the company in the past. Its ...

It’s made with plant-based ingredients that imitate the texture and appearance of true salmon.

The FDA has agreed to review its decision to remove Eli Lilly’s LLY tirzepatide — the active ingredient used in diabetes drug Mounjaro and obesity drug Zepbound — from its shortage list ...

The FDA removed Eli Lilly’s LLY tirzepatide injection products from the drug shortage list after determining that Lilly’s supply is currently meeting or exceeding demand and will continue to ...

The Food and Drug Administration (FDA) just green-lit a new Covid vaccine from Moderna, the company said in a press release Saturday.

Among other differences from FDA-approved drug products, compounded drug products have not undergone FDA premarket review for safety, effectiveness, or quality.

The FDA’s website states that ivermectin has not been approved in “preventing or treating” COVID-19, because it could not find substantial evidence that “ivermectin is safe or effective ...

Long-approved drugs with decades of safety data are facing new scrutiny amid a charged political environment. The Trump administration’s new “Make America Healthy Again (MAHA) Commission ...

The FDA published a database of letters sent to drugmakers during the review process of medications that provide information on the agency's initial feedback or requirements for more data. These ...

List of oncology drugs approved by the FDA in September 2024. Throughout the month of September, several cancer therapies were approved by the Food and Drug Administration (FDA) for diseases including ...