Federal regulators have warned a Waco, Texas, company that its human amniotic products are “unlicensed” and “unapproved,” and ...

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

Here’s what an executive order is, who can overturn it and how and a list of 12 impactful executive orders President Trump ...

The FDA didn't approve the therapy in EBV-positive post-transplant lymphoproliferative disease due to findings at a third-party manufacturing facility.

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 ...

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 ...

When the FDA turned down Lykos’ application for approval for its MDMA capsule along with psychological intervention, also known as MDMA-assisted therapy, in August 2024, the regulator explained ...

SAN FRANCISCO and SUZHOU, China, Jan. 16, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent ... Medical Products Administration (NMPA) has approved the New Drug Application (NDA) of ...

Omvoh is the first biological treatment for Crohn disease to have disclosed two-year phase 3 efficacy data at the time of approval in more than 15 years. The approval is based on results of the ...

Preapproval allows you to check your approval chances—and avoid hard inquiries—so you can apply confidently. Credit card preapproval means an issuer has reviewed your credit history using a ...

Building on the company's expertise in large-scale antibody manufacturing and process ... for biologics, which will increase total production capacity to 964,000 liters upon board approval.