With each new year comes a new set of accompanying challenges, from tackling the latest innovations to new incarnations of old issues. 2025 will be ...

Below is a review of novel drug and biological products approved by the Food and Drug Administration (FDA) in 2024. The list includes several groundbreaking therapies that are expected to change the ...

Biologic drugs are often stored in liquid form and administered by injection. These containers need to be sterile, capable of withstanding harsh conditions, such as cryogenic temperatures as low ...

In its most recent effort to keep pace with advancing technology, the US Food and Drug Administration (FDA) recently issued two draft guidances on ...

The U.S. Food & Drug Administration sent a warning letter to Frontier Biologics in November, outlining concerns about the company’s operations. But Frontier Biologics chief scientist Gene ...

The Biden administration’s selection of 15 new drugs for price negotiations is reigniting the call from opponents to amend how drugs can be selected for the Medicare program.

The confirmatory IGNYTE-3 trial is assessing RP1 in combination with nivolumab in patients with advanced melanoma who have progressed on anti-PD-1 and anti-CTLA-4 therapies or are ineligible for ...

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Federal regulators have warned a Waco company that its human amniotic products are “unlicensed” and “unapproved,” and that its manufacturing process violates safety regulations. The U.S. Food & Drug ...